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SOURCE BELIEVES THAT THE CAUSE OF THE IRRITATION MAY BE DUE TO THE WAY THE PT IS BEING PREPPED. SHE DID INDICATE THAT SHE DID NOT KNOW IF THE ALCOHOL WAS BEING ALLOWED TO DRY THO ROUGHLY USED TO PREP THE PT'S SKIN PRIOR TO ELECTRODE APPLICATION. THE ABSENCE OF THOROUGH DRYING MAY HAVE CONTRIBUTED TO THIS PROBLEM. THE PT REPORTEDLY EXPIRED DUE TO ASYSTOLE. THE CENTRAL COMPONENT DID NOT ALARM WHEN THE PT WENT INTO ASYSTOLE. THE PT EXPIRED. PRACTITIONER REPORTED THAT PATIENT WAS DISPENSED LENSES BY ANOTHER OFFICE AND CAME TO THEM 8 MONTHS LATER WITH PROBLEMS. THE PATIENT HAS HAD SEVERAL EPISODES OF KERATITIS OF UNKNOWN ETIOLOGY OVER THE PAST YEAR, SOME OF WHICH REQUIRED PRESCRIPTION ME DICATION. THE PATIENT WAS REFIT INTO ANOTHER LENS TYPE AND IS DOING WELL. THE PRACTITIONER REPORTED THAT THE PATIENT HAD POOR COMPLIANCE AND THEY HAVE REINFORCED CARE AND CLEANING OF THE LENSES. PATIENT REPORTS THAT SHE RECEIVED REPLACEMENT LENSES AND AFTER FOUR WEEKS OF USE EXPERIENCED SYMPTOMS OF DISCOMFORT, REDNESS AND DISCHARGE OF THE LEFT EYE ONLY. SHE WAS ALLEGEDLY DIAGNOSED WITH CONJUNCTIVITIS AND TREATED. THE PATIENT REPORTS THAT THE CONDITION CLEARED AND SHE WAS READY TO RESUME LENS WEAR. THE TREATING PRACTITIONER WOULD ONLY CONFIRM THAT THE PATIENT WAS SEEN BUT WOULD NOT RELEASE ANY INFORMATION WITHOUT PATIENT CONSENT. THE PATIENT WAS TO ARRANGE FOR RELEASE OF THIS INFORMATI ON BUT LEFT THE COUNTRY FOR A PERIOD OF TIME AND DID NOT CONTACT THE OFFICE. PATIENT PURCHASED A PAIR OF EXTENDED WEAR CONTACT LENSES AND IMMEDIATELY COMPLAINED OF DISCOMFORT. THE OPTICIAN ADVISED HIM THAT HE WOULD ADAPT TO THE LENSES HOWEVER HE CONTINUED TO EXPERIENCE DISCOMFORT AND REDNESS OF THE LEFT EYE. PATIENT WENT TO THE HOSPITAL ER WHERE HE WAS ALLEGEDLY DIAGNOSED WITH A CORNEAL ABRASION O.S. AND PRESCRIBED AN ANTIBIOTIC DROP. THE OPTICIAN'S TELEPHONE NUMBER PROVIDED BY THE REPORTER REACHES A RECORDED MESSAGE OF ADVERTISEMENTS AND BUSINESS HOURS ONLY. CURRENTLY THERE IS NO VERIFICATION OF THE EVENT, LENS TYPE OR MANUFACTURER. A CERTIFIED LETTER HAS BEEN SENT TO THE OPTICIAN REQUESTING FOLLOW UP.THE PRODUCT WAS RETURNED TO THE OPTICIAN BY THE PATIENT. PATIENT RECEIVED REPLACEMENT LENSES AND WORE FOR 6 WEEKS WITH NO PROBLEMS. HER EYES HAD BEEN DRY FOR A FEW DAYS AND SHE REPORTS USING AN ENTIRE BOTTLE OF REWETTING DROPS AND EXPERIENCING REDNESS, BURNING, PHOTOPHOBIA AND SWOLLEN UPPER LID.SHE INSERTE D HER LEFT LENS AND IT HURT. SHE WENT TO THE HOSPITAL ER AND DIAGNOSIS WAS 5 INFILTRATES/ULCERS. A CULTURE GREW ECOLI AND AN ANTIBIOTIC WAS PRESCRIBED. FOLLOW UP SHOWED ONE AREA OF STAINING AND MEDICATION WAS CONTINUED. A TEAR WAS NOTED IN THE LE NS BY THE DOCTOR WHO THOUGHT THE TEAR MAY HAVE CAUSED ANABRASION WHICH BECAME INFECTED. 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" #x %AccessVBAWin16~Win32MacVBA6#mdr.mdbDAOstdole`VBIDEAH   ID="{A8506472-FB45-4AC6-8FFB-09A2571F0749}" Name="mdr.mdb" HelpContextID="0" VersionCompatible32="393222000" CMG="DEDC0B6F37931197119711971197" DPB="BCBE694D992A9A2A9A2A" GC="9A984FB32CB42CB4D3" [Host Extender Info] &H00000001={3832D640-CF90-11CF-8E43-00A0C911005A};VBE;&H00000000 [Workspace] ijMSysDbAcessVBAData4Forms  @he@heCmdbars@he@heModules @he@heReports@he@heScripts @he@hePropData5Databases@he@he0@he@heBlob DirData6CustomGroups@he@heDataAccessPages @he@he e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p t et e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p w txo(4g +PApjn(˯53:w* NeXb=*b%Ih ~y6$ OX. ꔋ_$B5p v Tt e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p @t e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p w v t e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p w t e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p w txo(4g +PApjn(˯53:w* NeXb=*b%Ih ~y6$ OX. ꔋ_$B5p v w txo(4g +PApjn(˯53:w* NeXb=*b%Ih ~y6$ OX. ꔋ_$B5p v w txo(4g +PApjn(˯53:w* NeXb=*b%Ih ~y6$ OX. ꔋ_$B5p v w Ttxo(4g +PApjn(˯53:w* NeXb=*b%Ih ~y6$ OX. ꔋ_$B5p v  w  txo(4g +PApjn(˯53:w* NeXb=*b%Jhv{@Ҡv{@TempMSysAccessObjectsvLLLLLLLLLLJ }v{@}v{@DataAccessPagesv@@@@@@@@@@> bvQw@vQw@PROCODESvO@ >>>22222220 @Gor@or@MSysIMEXSpecsv<<<<<<<<<<: or@’r@MSysIMEXColumnsv@@@@@@@@@@> :gvQw@vQw@MDRv@ 444(((((((& @ ]or@]or@UserDefinedv88888888886  or@or@SummaryInfov~@ DDD88888886 @ 8ӗxr@C}v{@AccessLayoutv4MR2KeepLocal T@ zz:::::::8 @or@or@SysRelv..........,  hor@ hor@Scriptsv0000000000.  hor@ hor@Reportsv0000000000. or@or@Modulesv0000000000.  hor@ hor@Formsv,,,,,,,,,,* `[or@`[or@MSysRelationshipswDDDDDDDDDDB `[or@`[or@MSysQueriesw88888888886 `[or@`[or@MSysACEsw22222222220 `[or@`[or@MSysObjectsw88888888886 `[or@ayv{@MSysDbv@ :::......., @`[or@`[or@Relationshipsw<<<<<<<<<<: `[or@`[or@Databasesw44444444442 `[or@`[or@Tablesw..........,                        ! E F G H 5 6 7 I % & 8 9 : ; < = " # $ ' ( ) * + , - . / 0 1 2 3 4 > ? @ A B C D             WERE STABLE. HER DR FELT SHE COULD BE MONITORED AT HOME. AT 4:15 AM SHE WOVERDELIVERY OF DOBUTAMINE DUE TO USER MISPROGRAMMING REPORTED. THE PT WAS A 13-YR-OLD GIRL (DOB 2/6/82) WITH A HISTORY OF AIDS AND SEVERE WASTING. THE PUMP WAS TO BE SET TO INFUSE DOBUTAMINE 274 MG IN 100 ML OF D5W OVER APPROX 4 DAYS (99 HRS). THE P UMP WAS INADVERTENTLY SET FOR A DELIVERY PERIOD OF "4.0:0" WHICH IS 4 HRS, NOT 4 DAYS. THE OVERDELIVERY OCCURRED FROM 6:30 PM TO 10:30 PM. THE HOME HEALTH AGENCY WAS NOTIFIED AND A NURSE ARRIVED TO ASSESS THE PT. SHE HAD NO ADVERSE SYMPTOMS AND HER V ITAL SIGNS WERE STABLE. HER DR FELT SHE COULD BE MONITORED AT HOME. AT 4:15 AM SHE WOKE UP FEELING "RESTLESS". HER DR FELT SHE MIGHT BE VOLUME OVERLOADED (SHE ALSO RECEIVES TPN) AND HAD HER BROUGHT TO THE ER. CARDIOLOGY ASSESSMENT, INCLUDING EKG AND ECHOCARDIOGRAM, WAS NORMAL FOR HER CONDITION. SHE WAS SENT HOME BY 7:30 AM. THERE WERE NO SYMPTOMS OF ANY ADVERSE REACTION AND THE DOBUTAMINE WAS RESTARTED. SHE WAS READMITTED TO THE HOSP ON 1/7/96 FOR "DISEASE PROGRESSION"AND SHE EXPIRED LATE THAT N IGHT. THE CAUSE OF DEATH WAS DETERMINED TO BE DUE TO HER "DISEASE PROCESS". PHYSICIANS DID NOT FEEL THE DOBUTAMINE OVERDELIVERYCONTRIBUTED. NO ADD'L INFO IS AVAILABLE. WHEN THE DEVICE WAS CONNECTED TO A PT IN FULL ARREST, THE DEVICE REPEATEDLY AND INAPPROPRIATELY INDICATED MOTION DETECTED. THE PT WAS NOT RESUSCITATED. AN 82-YR-OLD FEMALE RESIDENT WAS FOUND WITH HER BODY BETWEEN THE TWO SIDERAILS. HER CHIN WAS RESTING ON TOP OF THE UPPER RAIL AND HER BOTTOM WAS 1 INCH OFF THE FLOOR. PT WAS IN RESTRAINTS AND PT HAD EXPIRED. MEDICAL EXAMINER RULED DEATH BY ASPHYXIATI ON. THE PT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. SURGEON IN AN ADJACENT OPERATING ROOM OPENED THE DEVICE'S UNIT PACKAGE AND REMOVED THE EXTENSION (FLEX TUBE). IN THE OPERATING ROOM WHERE THE DEVICE WAS TO BE USED, THE ANESTHESIA CIRCUIT AND MACHINE WERE CHECKED FOR PRESSURE AND LEAKS. THE DEVICE WA S SUBSEQUENTLY INSTALLED IN THE INSPIRATORY PORT OF THE MACHINE, NO PRESSURE OR LEAK TEST WAS THEN PERFORMED. IT WAS OBSERVED THAT THE PT WAS NOT BEING VENTILATED. THE DEVICE WAS REMOVED FROM THE CIRCUIT. THE PT CONTINUED NOT TO BE VENTILATED, AND WA S MANUALLY VENTILATED, AND EXUBATED. IT WAS NOTICED THAT THE OBSTRUCTION TO VENTILATION WAS A CAP, (WHICH IS SUPPLIED IN THE UNIT PACKAGE, TO BE USED TO COVER THE OPENING OF THE FLEX TUBE) LODGED IN THE MACHINE'S INSPIRATORY PORT. IT WAS SURMISED THA T THE CAP WAS CARRIED ALONG WITH THE DEVICE TO INSPIRATORY PORT WHERE IT BECAME LODGED DURING THE INSTALLATION OF THE DEVICE. THE Pt e4g,y5'+~xn(˯53:w* NeXtLjx@e*w0Y$)$ OX. ꔋ_$B5p  ZerosDateOrderDecimalPointFieldSeparatorFileType SpecIDSpecNameSpecTypeStartRowTextDelimTimeDelim///YPrimaryKeyiv'v{@v'v{@MSysIMEXSpecs::::::::::: 7'v{@v'v{@MSysIMEXColumns>>>>>>>>>>> 3 v{@7'v{@MDR&&&&&&&&&&&  3 v{@3 v{@UserDefined66666666666  3 v{@3 v{@SummaryInfo66666666666  3 v{@3 v{@AccessLayout88888888888 3 v{@3 v{@SysRel,,,,,,,,,,, 3 v{@3 v{@Scripts........... 3 v{@3 v{@Reports........... 3 v{@3 v{@Modules........... 3 v{@3 v{@Forms*********** v{@v{@MSysRelationshipswDDDDDDDDDDB v{@v{@MSysQueriesw88888888886 v{@v{@MSysACEsw22222222220 v{@v{@MSysObjectsw88888888886 v{@v{@MSysDbv.........., v{@v{@Relationshipsw<<<<<<<<<<: v{@v{@Databasesw44444444442 v{@v{@Tablesw..........,       ,d _ Z g  ~ ) w  f@OJmJLJkQkSdi`k`dOo^Qk iQ^JmYdbkWYfkiQfdimk kMiYfmk kvkiQ^ mJL^Qk`Oi`kvkJMQk`kvkY`QuMd^o`bk`kvkY`QukfQMk`kvkdL[QMmk`kvkhoQiYQk`kvkiQ^JmYdbkWYfkJMMQkk^Jvdom `kvkOLko``JivYbSdokQiOQSYbQObvQw@vQw@PROCODESO@ >>>22222220 @Gor@or@MSysIMEXSpecs<<<<<<<<<<: or@’r@MSysIMEXColumns@@@@@@@@@@> hv{@Ҡv{@MSysAccessObjectsDDDDDDDDDDB :gvQw@vQw@MDR@ 444(((((((& @ ]or@]or@UserDefined88888888886  or@or@SummaryInfo~@ DDD88888886 @ 8ӗxr@-Fv{@AccessLayout4MR2KeepLocal T@ zz:::::::8 @or@or@SysRel..........,  hor@ hor@Scripts0000000000.  hor@ hor@Reports0000000000. or@or@Modules0000000000.  hor@ hor@Forms,,,,,,,,,,* }v{@}v{@DataAccessPages@@@@@@@@@@> `[or@`[or@MSysRelationshipsDDDDDDDDDDB `[or@`[or@MSysQueries88888888886 `[or@`[or@MSysACEs22222222220 `[or@`[or@MSysObjects88888888886 `[or@ayv{@MSysDb@ :::......., @`[or@`[or@Relationships<<<<<<<<<<: `[or@`[or@Databases44444444442 `[or@`[or@Tables.........., 3 YN `jQ Y  Y  Y d Y  Y d Y  Y 2 Y 2 Y  F Y   Y   Y I FDAIDDATERECDPRODNAMESHRTNAMEMFGNAME INJURY MODNO CATNOSPECIALTYPROCODE EDTYPEDESCRIPTIONkn  svz }YYYYYYY ACCESSMFGNAMEPROCODERPTTYPESHRTNAMESPECIALTY 7'v{@v'v{@MSysIMEXColumns>>>>>>>>>>> 3 v{@7'v{@MDR&&&&&&&&&&&  3 v{@3 v{@UserDefined66666666666  3 v{@3 v{@SummaryInfo66666666666  3 v{@3 v{@AccessLayout88888888888 3 v{@3 v{@SysRel,,,,,,,,,,, 3 v{@3 v{@Scripts........... 3 v{@3 v{@Reports........... 3 v{@3 v{@Modules........... 3 v{@3 v{@Forms*********** v{@v{@MSysRelationshipswDDDDDDDDDDB v{@v{@MSysQueriesw88888888886 v{@v{@MSysACEsw22222222220 v{@v{@MSysObjectsw88888888886 v{@v{@MSysDbv.........., v{@v{@Relationshipsw<<<<<<<<<<: v{@v{@Databasesw44444444442 v{@v{@Tablesw.........., , v1b N 88z߶]$ I LVAL# / DRECEIVED A REPORT THAT A CONTACT LENS ALLEGEDLY TORE WHILE IN THE PATIENT'S EYE.THE PATIENT RETURNED TO THE PRACTITIONER TO CHECK IF THE LEFT LENS WAS STILL IN THE EYE AND WAS REFERRED TO A CLINIC WHERE THE LENS WAS REMOVEDRECEIVED A REPORT THAT A CONTACT LENS ALLEGEDLY TORE WHILE IN THE PATIENT'S EYE.THE PATIENT RETURNED TO THE PRACTITIONER TO CHECK IF THE LEFT LENS WAS STILL IN THE EYE AND WAS REFERRED TO A CLINIC WHERE THE LENS WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ABRASION AND THE EYE WAS TREATED AND PATCHED. THE PATIENT RECOVERED AND RESUMED LENS WEAR. INSPECTION OF THE LENS REVEALED THAT THE LENS MAY HAVE TORN DUE TO A SMALL PUNCTURE. DISPENSER REPORTS THAT PATIENT WAS DISPENSED TWO PAIRS OF CONTACT LENSES, ONE CLEAR AND ONE AQUA COLOR. PATIENT RETURNED TWO AND A HALF MONTHS LATER REPORTINGTHAT SHE HAD BEEN TREATED FOR CONJUNCTIVITIS. SHE IS A NURSE AND SAW THE ON CALL PHYSICIAN WHO ALLEGEDLY DIAGNOSED THE CONDITION AND PRESCRIBED MEDICATION. THE CONDITION CLEARED AND THE PATIENT RESUMED LENS WEAR WITH NO RECURRENCE. THEREIS NO VERIFICATION OF THE EVENT. THE FOUR LENSES WERE RETURNED AND COSMETIC INSPECTION REVEALED A PA RTICLE ON ONE LENS. NO OTHER UNUSUAL QUALITIES WERE OBSERVED WHICH WOULD CAUSE THE PATIENT'S SYMPTOMS. PATIENT RECEIVED TRIAL PAIR OF CONTACT LENSES AND WORE THEM DAILY FOR ABOUT A WEEK UNTIL THE LEFT LENS GOT WHAT APPEARED TO BE DIRT STUCK IN THE LASER MARK AREA. THE EYE CARE PRACTITIONER REPORTS THAT THE MATERIAL WAS OPAQUE, IN THE AREA BETWEEN TWO LASER MARKS AND COULD NOT BE REMOVED. HE REPORTS THAT THE MATERIAL WAS NOT PRESENT WHEN THE LENS WAS DISPENSED. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH A CORNEAL ULCER O.S. IN THE LOCATION OF THE FOREIGN MATERIAL. THE ULCER RESOLVED WITH TREAT MENT. NO CULTURES WERE TAKEN. THE PRODUCT WAS NOT RECEIVED FOR ANALYSIS. PATIENT REPORTS THAT HE WORE HIS CONTACT LENS FOR 6 MONTHS WITH NO PROBLEMS. HE REPORTED THAT ON ONE DAY HIS LENS WAS UNCOMFORTABLE. HE TRIED TO REMOVE THE LENS AND STATED ONLY A PIECE WAS REMOVED. PATIENT WENT TO HOSPITAL ER. THE DOCTOR DID NOT F IND ANY OTHER CONTACT LENS PIECES AND STATED THAT THE CORNEA WAS SLIGHTLY SCRATCHED AND AS A PREVENTITIVE MEASURE, PRESCRIBED MEDICATION. THE PATIENT DID NOT FILL THE PRESCRIPTION. THE PATIENT LATER WENT TO AN OPHTHALMOLOGIST WHO REPORTED THE EYE W AS IRRITATED DUE TO A TORN LENS AND ADVISED THE USE OF A LUBRICANT DROP FOR THE IRRITATION. THE PATIENT HAS SINCE RESUMED LENS WEAR. THE LENS PIECE WAS RETURNED AND INSPECTION REVEALED THAT THE LENS MAY HAVE TORN DUE TO A SMALL PUNCTURE. PATIENT IS A 40 YEAR OLD APHAKIC WHO CAME IN FOR AN EXAM WITH 2 MM. NEOVASCULARIZATION. THE LENS WAS COATED WITH PROTEIN. DISCUSSION WITH THE PRACTITIONER INDICATED THAT THE NEOVASCULARIZATION WAS CAUSED BY A COMBINATION OF CONTACT LENS WEAR, NON C OMPLIANCE AND PHYSIOLOGICAL RESPONSE OF THE PATIENT. THE PATIENT WAS REFIT INTO A THINNER LENS TYPE. AT A FOLLOW UP THE NEOVASCULARIZATION HAD REMAINED THE SAME AND THE VISION WAS POOR SO THE PRACTITIONER WAS GOING TO REFIT THEPATIENT AGAIN. PATIENT HAS WORN THIS LENS TYPE FOR 6-8 YEARS. SHE HAS ALLERGIES AND WEARS LENSES AS DAILY WEAR. SHE RECEIVED NEW LENSES AND UPON INSERTION THE LEFT LENS WAS UNCOMFORTABLE AND VISION BLURRY. SHE WORE THE LENS FOR 1/2 HOUR AND HER EYE WAS RED.THE LE NS WAS RETURNED TO THE DISPENSER AND SHE WAS GIVEN A DISPOSABLE TO WEAR WHILE A NEW LENS WAS ORDERED. SHE RECIEVED THE NEW LENS OF A DIFFERENT LOTNUMBER AND EXPERIENCED THE SAME SYMPTOMS. SHE SAW A GENERAL PRACTITIONER AND ALTHOUGH SHE WAS DIAGNOSE D WITH IRITIS, SHE WAS PRESCRIBED AN ANTIBACTERIAL AGENT.SINCE, THE PATIENT HAS RECEIVED A NEW LENS WHICH SHE IS WEARING WITH NO PROBLEMS. ONE LENS WAS RETURNED AND INSPECTION FOUND ALL QUALITIES TO BE WITHIN SPECIFICATION. J[_  o H S\[j 743261960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 100090025CARDIOVASCULARMKJF@ymkfVOF?(   743259960105AMBULANCE COTFERNWASHFERNO-WASHINGTON, INC.SERIOUS INJURY35A35AGEN HOSPITALFPOF@~rpk]XSC+!   743169960102NON PVC ULTRA-CONNECTOR WITH MALE LUER SLIPMEDEXMEDEX, INC.SERIOUS INJURYNAMX453-HGEN HOSPITALFPAF@~pgcSF?   743129960103COMPONENT CENTRAL MONITORHEWLPACKHEWLETT-PACKARD CO.DEATHM2350AM2350ACARDIOVASCULARDRTPZ@zxsc[SL7-   743064960102BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500ANESTHESIOLOGYFLSP@vto__YR9/   742869960104DOBBHOFF FEEDING TUBESHERMEDISHERWOOD MEDICAL CO.SERIOUS INJURYNA8881-710834GASTRO & UROLOGYFPDF8@|j]YI3)   742868960104CLEARTRACE ECG ELECTRODESCONMEDCONMED CORP.SERIOUS INJURYNA2700-001CARDIOVASCULARDRXF@xvqaWSC5-   742847960102CADENCE V-100 SERIES TIERED THERAPY DEFIBRILLATORVENTRITEXVENTRITEX, INC.DEATHV-100CV-100CCARDIOVASCULARLWSPg@xphaPE   707843960216ACCUFIXTELEPACISYSTTELECTRONICS PACING SYSTEMS, INC.DEATH330-8010330801CARDIOVASCULARDTBPN@|zue\SL)   707646960124GUARDIANTELEPACISYSTTELECTRONICS PACING SYSTEMS, INC.DEATH4210040004CARDIOVASCULARLWSP@ywrbZTM*   707644960111OPTIMA MPT SERIES IITELEPACISYSTTELECTRONICS PACING SYSTEMS, INC.DEATH5281BU32101CARDIOVASCULARDXYPp@og`Y6(   571074960115SEEQUENCE (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF@zxsgc_O@6   571073960115MEDALIST TORIC (LIDOFILCON A) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF@{okgWH>   571072960115SEEQUENCE2 (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF7@{ythd`PA7   571071960115OPTIMA FW (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF@zxsgc_O@6   571070960115MEDALIST (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMFI@ywrfb^N?5   571069960115UNBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF@fZXSGC?/    571068960115OPTIMA 38 (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPLF)@zxsgc_O@6   571067960115OPTIMA TORIC (HEFILCON B) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPLF@~|wkgcSD:   571066960115OPTIMA FW (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMFd@zxsgc_O@6   571065960115GOLD MEDALIST TORIC (HEFILCON C) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPLFG@~rnjZKA   571064960115OPTIMA TORIC (HEFILCON B) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPLF@~|wkgcSD:   571063960115SOFLENS B3 (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPLF@{ythd`PA7   571062960115SOFLENS O4 (POLYMACON) CONTACT LENSBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNANAOPHTHALMICLPMF@{ythd`PA7  hLVAL   ~@ Dw-dp@@ Dw.p@%(@THE PUMP "GAS LOSS ALARM" SOUNDED. NO BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT THEN WENT INTO CARDIAC ARREST. AT THIS TIME, BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT WENT THE PUMP "GAS LOSS ALARM" SOUNDED. NO BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT THEN WENT INTO CARDIAC ARREST. AT THIS TIME, BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT WENT ONTO EXPIRE. PT STATUS: EXPIRED RPT'D 1/3/96. THE PRODUCT IN THIS EV ENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSP. THE FILE IS CONSIDERED CLOSED. ULCERATIONS FOUND UNDER THE ELECTRODE. NO FOLLOW-UP TREATMENT REQUIRED. SOURCE BELIEVES THAT THE CAUSE OF THE IRRITATION MAY BE DUE TO THE WAY THE PT IS BEING PREPPED. SHE DID INDICATE THAT SHE DID NOT KNOW IF THE ALCOHOL WAS BEING ALLOWED TO DRY THO ROUGHLY USED TO PREP THE PT'S SKIN PRIOR TO ELECTRODE APPLICATION. THE ABSENCE OF THOROUGH DRYING MAY HAVE CONTRIBUTED TO THIS PROBLEM. THE PT REPORTEDLY EXPIRED DUE TO ASYSTOLE. THE CENTRAL COMPONENT DID NOT ALARM WHEN THE PT WENT INTO ASYSTOLE. THE PT EXPIRED. PRACTITIONER REPORTED THAT PATIENT WAS DISPENSED LENSES BY ANOTHER OFFICE AND CAME TO THEM 8 MONTHS LATER WITH PROBLEMS. THE PATIENT HAS HAD SEVERAL EPISODES OF KERATITIS OF UNKNOWN ETIOLOGY OVER THE PAST YEAR, SOME OF WHICH REQUIRED PRESCRIPTION ME DICATION. THE PATIENT WAS REFIT INTO ANOTHER LENS TYPE AND IS DOING WELL. THE PRACTITIONER REPORTED THAT THE PATIENT HAD POOR COMPLIANCE AND THEY HAVE REINFORCED CARE AND CLEANING OF THE LENSES. PATIENT REPORTS THAT SHE RECEIVED REPLACEMENT LENSES AND AFTER FOUR WEEKS OF USE EXPERIENCED SYMPTOMS OF DISCOMFORT, REDNESS AND DISCHARGE OF THE LEFT EYE ONLY. SHE WAS ALLEGEDLY DIAGNOSED WITH CONJUNCTIVITIS AND TREATED. THE PATIENT REPORTS THAT THE CONDITION CLEARED AND SHE WAS READY TO RESUME LENS WEAR. THE TREATING PRACTITIONER WOULD ONLY CONFIRM THAT THE PATIENT WAS SEEN BUT WOULD NOT RELEASE ANY INFORMATION WITHOUT PATIENT CONSENT. THE PATIENT WAS TO ARRANGE FOR RELEASE OF THIS INFORMATI ON BUT LEFT THE COUNTRY FOR A PERIOD OF TIME AND DID NOT CONTACT THE OFFICE. PATIENT PURCHASED A PAIR OF EXTENDED WEAR CONTACT LENSES AND IMMEDIATELY COMPLAINED OF DISCOMFORT. THE OPTICIAN ADVISED HIM THAT HE WOULD ADAPT TO THE LENSES HOWEVER HE CONTINUED TO EXPERIENCE DISCOMFORT AND REDNESS OF THE LEFT EYE. PATIENT WENT TO THE HOSPITAL ER WHERE HE WAS ALLEGEDLY DIAGNOSED WITH A CORNEAL ABRASION O.S. AND PRESCRIBED AN ANTIBIOTIC DROP. THE OPTICIAN'S TELEPHONE NUMBER PROVIDED BY THE REPORTER REACHES A RECORDED MESSAGE OF ADVERTISEMENTS AND BUSINESS HOURS ONLY. CURRENTLY THERE IS NO VERIFICATION OF THE EVENT, LENS TYPE OR MANUFACTURER. A CERTIFIED LETTER HAS BEEN SENT TO THE OPTICIAN REQUESTING FOLLOW UP.THE PRODUCT WAS RETURNED TO THE OPTICIAN BY THE PATIENT. PATIENT RECEIVED REPLACEMENT LENSES AND WORE FOR 6 WEEKS WITH NO PROBLEMS. HER EYES HAD BEEN DRY FOR A FEW DAYS AND SHE REPORTS USING AN ENTIRE BOTTLE OF REWETTING DROPS AND EXPERIENCING REDNESS, BURNING, PHOTOPHOBIA AND SWOLLEN UPPER LID.SHE INSERTE D HER LEFT LENS AND IT HURT. SHE WENT TO THE HOSPITAL ER AND DIAGNOSIS WAS 5 INFILTRATES/ULCERS. A CULTURE GREW ECOLI AND AN ANTIBIOTIC WAS PRESCRIBED. FOLLOW UP SHOWED ONE AREA OF STAINING AND MEDICATION WAS CONTINUED. A TEAR WAS NOTED IN THE LE NS BY THE DOCTOR WHO THOUGHT THE TEAR MAY HAVE CAUSED ANABRASION WHICH BECAME INFECTED. ONE WEEK LATER THE ULCER HAD RESOLVED AND THE PATIENT COULD RESUME LENS WEAR. VISION WAS 20/20. PATIENT'S HISTORY REVEALED APARACENTRAL INFILTRATE IN 1994. PA TIENT AND DOCTOR WERE TO REVIEW OTHER LENS TYPES. LVAL Sh)<PT SAYS HE LEANED ON SIDERAIL AND IT GAVE WAY, HE FELL TO FLOOR. NO WITNESSES. PT RECEIVED SOME PARALYSIS. PT EXPIREDPT SAYS HE LEANED ON SIDERAIL AND IT GAVE WAY, HE FELL TO FLOOR. NO WITNESSES. PT RECEIVED SOME PARALYSIS. PT EXPIRED 1/4/96. BED TESTED BY SVC AND FOUND THAT SIDERAILS OPERATED PROPERLY, SIDERAIL OPERATION COVERED IN USER MANUAL. DURING SURGERY WITH FRAME PT ALLEGEDLY EXPERIENCED DECREASED VISION IN THE RIGHT EYE. PT IS 57-YR-OLD. DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. PT PRESENTED WITH SHORTNESS OF BREATH AND COMPLAINTS OF GENERAL MALAISE. PT IN ATRIAL FIBRILLATION WITH ATRIAL THROMBOSIS NOTED ALONG LEAD. LAB FINDINGS REVEALED DIC. PT DEVELOPED PULMONARY EMBOLUS WITH PROGRESSIVE DYSPNEA, CONTINUED DETERIORATION LE ADING TO CARDIAC ARREST. POST MORTEM REVEALED LEFT MAIN AND RIGHT DISTAL ARTERIES WERE THROMBOSED. THE DEVICE WAS RETURNED FOR EVALUATION. PRODUCT OVERHEATED FOR A PROLONGED TIME CAUSING SEVERE BODILY INJURIES. SUBSEQUENT INFO RECEIVED ADVISED CONSUMER, A DIABETIC, FELL ASLEEP WITH THE HEAT PAD ON HIS ANKLE CONTRARY TO INSTRUCTIONS. NO ADD'L INFO HAS BEEN RECEIVED. REPORT RECEIVED OF SUDDEN DEATH ON 12/30/95. AT LAST PACEMAKER CHECK ON 12/12/95 PACER FUNCTION WAS NORMAL. PACER IS REPORTED AS UNABLE TO TELEMETER AND HAVING NO OUTPUT. THE PACER WILL BE RETURNED FOR ANALYSIS. LEAD MODEL NO 030-220 SERIAL NO 13391 WAS IN USE WITH THIS PACEMAKER. IMPLANT DURATION: 33 MOS. PRODUCT SAFETY ALERT INITIATED IN THE US N-027/029-5. INITIAL REPORT INDICATED THAT THE PATIENT COMPLAINED OF "LITTLE CUTS IN HIS EYESFROM THE LENSES AND THAT HIS EYES WERE CHECKED IN THE HOSPITAL". A FOLLOW UP WITH THE PRACTITIONER REVEALED THAT THE PATIENT NEVER SOUGHT MEDICAL CARE AT THE HOSPITAL. TH E PRACTITIONER REPORTS THAT HE DID NOT SEE ANYTHING UNUSUAL WITH THE PATIENT'S EYE OR THE LENS. THE PATIENT EXPERIENCED DISCOMFORT UPON INSERTION & TRIED A SECOND LENS. THE DISCOMFORT PERSISTED. THE PRACTITIONER ADVISED NO LENS WEAR FOR 2 WEEKS A ND THEN THE PATIENT RESUMED LENS WEAR WITH NO PROBLEMS.INSPECTION OF THE TWO LENSES RETURNED REVEALED THAT ONE LENS HAD AN IRREGULAR SURFACE AND THE SECOND WAS WITHIN SPECIFICATION. IT CANNOT BE DETERMINED IF THESURFACE IRREGULARITY WOULD HAVE CAUSE D THE PATIENT'S DISCOMFORT. PATIENT'S MOTHER REPORTS THAT HER SON WAS WEARING A 50% WATER TORIC LENS SUCCESSFULLY FOR 5 YEARS AND THEN WAS REFIT INTO A 70% WATER TORIC LENS. HE HAS MANY ALLERGIES AND DRY EYES. HE EXPERIENCED SYMPTOMS OF BURNING AND DRY EYES. WHEN HE RETURNED TO THE DISPENSER HE WAS GIVEN DROPS FOR THE SYMPTOMS. THE LENSES WERE DISCARDED. HE RETURNED TO SCHOOL AND THE CONDITION DID NOT IMPROVE SO HE SAW AN OPHTHAMOLOGIST WHO DIAGNOSED CONJUNCTIVITIS. THE CONDITION CLEARED WITH TREATMENT. HE THEN TRIED A 2ND AND 3RD PAIR AND EXPERIENCED THE SAME SYMPTOMS. HE THEN WENT TO ANOTHER PRACTITIONER WHO REFIT HIM BACK INTO THE TORIC LENS HE WAS PREVIOUSLY WEARING AND HE HAS HAD NO FURTHER PROBLEMS. ONE PAIR OF LENSES ARE TO BE RETURNED FOR EVALUATION. PATIENT REPORTS THAT SHE HAS WORN CONTACT LENSES FOR 20 YEARS AND ORDERS HER LENSES THROUGH A MAIL ORDER COMPANY. SHE REPORTS THAT HER LAST SUPPLY OF LENSES "SEEMED CLOUDY" AND AT THE END OF THE DAY HER EYES WERE RED AND ITCHY. SHE WENT TO A GENERA L PRACTITIONER WHO ALLEGEDLY PRESCRIBED MEDICATION FOR THE SYMPTOMS AND SAID IT COULD BE A VIRUS. THE CONDITION CLEARED. SHE PUT IN A NEW PAIR OF LENSES AND EXPERIENCED THE SAME SYMPTOMS. SHE WENT TO AN URGENT CARE DOCTOR AT THE SAME CLINIC AND WA S ALLEGEDLY DIAGNOSED WITH CONJUNCITIVITIS. WITH MEDICATION THE SYMPTOMS CLEARED IN 2 DAYS. WHEN SHE RESUMED LENS WEAR WITH A NEW PAIR SHE HAD NO PROBLEMS BUT THEN FOLLOWING CLEANING AND DISINFECTION WHEN SHE WORE THEM A 2ND TIME SHE EXPERIENCED RE DNESS. PATIENT WILL REVIEW WEAR AND CARE WITH HER OPTOMETRIST. LVAL E 92THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. A CRACKING SOUND WAS HEARD BEFORE THE DEVICE WAS WITHIN FIRING RANGE. A SECONTHE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. A CRACKING SOUND WAS HEARD BEFORE THE DEVICE WAS WITHIN FIRING RANGE. A SECOND DEVICE WAS INTRODUCED AND FIRED. SURGEON DID A LEAK TEST AND DISCOVERED LEAKAGE. SURGEON PROCEEDED IN CREATING A COLOS TOMY. THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY. THE SURGEON NOTED FOUR HOLES IN BOWEL, WHICH WAS ATTRIBUTED TO THE USE OF THE DEVICE. CASE WAS CONVERTED TO AN OPEN PROCEDURE TO REPAIRL BOWEL. DEVICE SEPARATED FROM ANOTHER MFRS DEVICE DURING USE. THE PT REQUIRED TRANSFUSION TO REPLACE LOST BLOOD. FOLLOW UP WITH CUSTOMER ON 1/10/96 INDICATED THIS HAD OCCURRED ON FOUR OTHER OCCASIONS BUT CUSTOMER DID NOT PROVIDE ANY OTHER DETAILS. REPORT OF INFANT DEATH BY HOMECARE DEALER. MONITOR REPORTEDLY ALARMED, CPR, WAS STARTED AND INFANT WAS TRANSPORTED TO HOSP. INFANT EXPIRED. DEVICE TO BE RETURNED TO MFR FOR EVALUATION AND TESTING. THE FEEDING TUBE WAS PLACED IN A PT. AN X-RAY REVEALED THAT THE TUBE WAS MISTAKENLY PLACED IN THE PT'S LUNG RATHER THAN IN THE STOMACH, AND A PNEUMOTHORAX RESULTED. THE DR REMOVED THE FEEDING TUBE AND ATTEMPTED TO PLACE A CHEST TUBE TO RELIEVE THE PN EUMOTHORAX. THE PT SUFFERED A CARDIAC ARREST AND DIED. BURNING SENSATION REPORTED UNDERNEATH ELECTRODE-BLISTERED SLIGHTLY. 6 WEEKS AFTER EVENT, PT REPORTS THAT THE ELECTRODE SITE REMAINS PAINFUL. AS A FOLLOW-UP TO A PT MAILING WHERE CO WAS INFORMED THAT THE PT HAD EXPIRED, A DEATH CERTIFICATE WAS REQUESTED. THE DEATH CERTIFICATE INDICATED THAT THE IMMEDIATE CAUSE OF DEATH WAS DUE TO MALIGNANT VENTRICULAR ARRHYTHMIA. NO OTHER INFO IS AVAILABLE AT THIST IME, AND THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT'S OUTCOME. PT WAS ADMITTED FOR EXTRACTION OF THE ATRIAL LEAD DUE TO THE RECALL. USING STANDARD TECHNIQUE AND TRACTION WITH COUNTER TRACTION THE LEAD WAS WITHDRAWN INTACT WITH A SMALL PIECE OF ATRIAL MYOCARDIUM ATTACHED. DURING REPLACEMENT THROUGH THE TRANSVENOU S APPROACH, THE PT BECAME HYPOTENSIVE. FLUOROSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE LEAD WAS OUTSIDE OF THE CARDIAC SILHOUETTE. A MEDIUM STERNOTOMY WAS MADE AND PERICARDIOTOMY PERFORMED. DISSECTION DISCLOSED THAT ONE OF THE ELECTRODES HAD PENE TRATED THE SUPERIOR VENA CAVA AND WAS INTO THE PLEURAL CAVITY. THE LEFT CHEST WAS OPENED AND A LARGE HEMOTHORAX WAS DISCOVERED. REPAIR OF THE SUPERIOR VENA CAVA WAS COMPLETED. THE PT STABILIZED AND WAS TRANSFERRED TO CSU. THE PT LATER DEVELOPED HYPOT ENSION WHICH PROGRESSED TO COMPLETE ELECTROMECHANICAL DISSOCIATION AND EXPIRED. THE PHYSICIANS FINAL DIAGNOSIS ON THE SUMMARY OF DEATH REPORT INDICATES: FAULTY PACEMAKER ELECTRODE, CARCINOMA OF THE BREAST, AND SICK SINUS SYNDROME. THE LEAD HAS NOT BE EN RETURNED FOR ANALYSIS. IMPLANT DURATION: 20 MONTHS. CORRECTIVE ACTION TAKEN: Z-209/211-5. THE EVENT OCCURRED DURING A CHRONIC ELECTROPHYSIOLOGY STUDY CONDUCTED AS A RESULT OF A CHANGE IN PT DRUG THERAPY, WHICH COULD HAVE AN EFFECT ON DEVICE SENSING OR DEFIBRILLATION THRESHOLDS. DURING THE STUDY, INDUCED VENTRICULAR TACHYCARDIAS (VT) WERE SUCCESSFULLY TERMINATED 3 TIMES. ON THE FOURTH ATTEMPT, THE VT WAS NOT APPROPRIATELY SENSED, AND EXTERNAL CARDIOVERSION WAS DELIVERED AND SINUS RHYTHM WAS RESTORED. ON THE FIFTH ATTEMPT, THE DEVICE DELIVERED 10 EPISODES OF ANTITACHYCARDIA PACING AND FAILED TO TERMINATE THE ARRHYTHMIA. UNSUCCESSFUL ATTEMPTS BY MANUAL DEVICE INTERVENTION WERE MADE, RESULTING IN THE NEED FOR EXTERNAL DEFIBRILLATION. THE TOTAL DURATION OF THE ARRHYTHMIA WAS APPROX ONE MINUTE. THE DEFIBRILLATION WAS SUCCESSFUL, BUT T HE PT HAD DEVELOPED ELECTRICAL/MECHANICAL DISSOCIATION AND RESUSCITATIVE EFFORTS WERE INITIATED. DESPITE THESE EFFORTS THE PT COULD NOT BE REVIVED AND WAS PRONOUNCED DEAD. IMPLANT DURATION: 47 MOS. >LVALiJ T V V  R-$`/ 745719960126MONOJECTOR SYRINGE HARDPACKSHERMEDISHERWOOD MEDICAL CO.SERIOUS INJURYNAGEN HOSPITALFPT, WHO HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED SUDDENLY ON DECEMBER 16, 1995. THE CAUSE OF THE DEATH WAS LISTED AS UNKNOWN: HOWEVER, THE FAX INDICATED THAT THERE WAS AN "ALLEGED MALFUNCTION OR PROBLEM". EPISODE DETAIL INDICATES 18 E PISODES OF FAST VENTRICULAR RHYTHM, LEADING TO SHOCK DELIVERY. HOWEVER, INPEDENCE MEASUREMENT INDICATE "OPEN CIRCUIT". A POST MORTEM EXAMINATION WAS NOT PERFORMED SO THE CONNECPT, WHO HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED SUDDENLY ON DECEMBER 16, 1995. THE CAUSE OF THE DEATH WAS LISTED AS UNKNOWN: HOWEVER, THE FAX INDICATED THAT THERE WAS AN "ALLEGED MALFUNCTION OR PROBLEM". EPISODE DETAIL INDICATES 18 E PISODES OF FAST VENTRICULAR RHYTHM, LEADING TO SHOCK DELIVERY. HOWEVER, INPEDENCE MEASUREMENT INDICATE "OPEN CIRCUIT". A POST MORTEM EXAMINATION WAS NOT PERFORMED SO THE CONNECTION AND LEAD INTEGRITY WERE NOT VERIFIED. THE FAX INDICATED THAT THE LEAD S WERE IMPLANTED IN 1986, HOWEVER AN ATTEMPT TO OBTAIN ADD'L INFO ON THE LEAD, INCLUDING MODEL AND SERIAL NUMBERS, HAS BEEN UNSUCCESSFUL. ICD IMPLANTED-11/5/92. TOTAL IMPLANT TIME-37 MO. CO DOES NOT KNOW IF THE ICD WAS EXPLANTED OR BURIED WITH THE PT . INFO RECEIVED FROM FOREIGN COUNTRY STATED THAT THE ICD WILL NOT BE RETURNED TO CO FOR ANALYSIS. DURING AN INCIDENT CALL INVOLVING A 36 YR OLD MALE PT WITH A CARDIAC HISTORY WHO WAS IN CARDIAC ARREST, THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS AND DID NOT DISPLAY THE PT'S RHYTHM. THE PT WAS NOT OBESE AND HIS SKIN WAS NOT MOIST. T HE OPERATORS CHECKED THE PADS AND THE DEVICE, AND POWERED THE DEVICE OFF AND ON AGAIN; BUT THE PROMPTS WOULD NOT CLEAR. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE. THE PT WAS TRANSPORTED TO A HOSP WHERE HE WAS PRONOUNCED. DURING TESTING BY THE CUST OMER BEFORE THE INCIDENT THE DEVICE FUNCTIONED PROPERLY. THE ELECTRODE PADS USED DURING THE INCIDENT WERE DISPOSED OF AT THIS HOSP AND ARE NOT AVAILABLE FOR EVALUATION. DEVICE WAS APPLIED TO A 91-YR-OLD MALE WITH A CARDIAC HISTORY WHO WENT TO SLEEP AND DID NOT WAKE UP AND WAS IN CARDIAC ARREST. THE DEVICE PERFORMED ONE DEVICE ASSESSMENT THAT RESULTED IN A "NO SHOCK INDICATED" PROMPT. THE DEVICE THEN REPORTEDLY DISPL AYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED THE PADS AND CABLES, BUT THE PROMPTS WOULD NOT CLEAR. FIRE DEPT PERSONNEL ADMINISTERED CPR WHILE THE OPERATORS POWERED THE DEVICE OFF AND ON AGAIN 4-5 TIMES. THREE ADD'L DEVICE ASSESSMENTS WERE T HEN PERFORMED WHICH ALSO RESULTED IN NO SHOCKS INDICATED. THE CUSTOMER INDICATES THE PT'S RHYTHM WAS ASYSTOLE DURING THE 3 ASSESSMENTS. CPR WAS ADMINISTERED UNTIL AN ALS TEAM ARRIVED AND ASSUMED PT CARE. THE PT WAS PRONOUNCED ON SCENE VIA TELEMETRY. DEVICE WAS APPLIED TO A FEMALE PT IN CARDIAC ARREST. THE PT LATER EXPIRED. THE CUSTOMER STATED THAT ALTHOUGH HE DOES NOT BELIEVE THE DEVICE MALFUNCTIONED, THE VOLUNTEER PERSONNEL AT THE SCENE WHICH WAS RELATED TO THE PT THINKS THE DEVICE DID NOT SHOC K THE PT WHEN IT SHOULD HAVE. CUSTOMER CLAIMS THAT AS THEY WERE REMOVING THE COT FROM THE AMBULANCE, THE SAFETY U BAR DID NOT CONNECT WITH THE STOP BLOCK. AS A RESULT, THE COT FOLDED TO THE GROUND. THE PT WAS POSITIONED ON A BACKBOARD WITH HER HEAD EXTENDING BEYOND THE EDGE OF TH E COT. AS THE COT FOLDED TO THE GROUND, THE PT'S HEAD CONTACTED THE BUMPER. THE REPORT STATES THAT THE PT RECEIVED A 'GOOSE EGG' BUT NOTHING FURTHER. gZ 7  .c;THE CA 743372960111BLUE MAX BALLOON DILATATION CATHETERBOSTSCIEBOSTON SCIENTIFIC CORP.DEATHNA273065CARDIOVASCULARLITF@~nfb[B8   743349960108BJORK-SHILEY CONVEXO-CONCAVE CARDIAC VALVE PROSTHESHILEYSHILEY, INC.DEATH29MBRCNICARDIOVASCULARLWQPC@okc\NF   743315960110ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ35WGEN & PLASTIC SURGERYGAGF@|xhL>   743314960109ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIELC60GEN & PLASTIC SURGERYGAGF@zso_C5   743313960109ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ35WGEN & PLASTIC SURGERYGAGF@|xhL>   743312960105ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER RELOETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEVU35GEN & PLASTIC SURGERYGAGF@}mQC   743311960105ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ45GGEN & PLASTIC SURGERYGAGF@|xhL>   743310960105PROXIMATE LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNITLC75GEN & PLASTIC SURGERYGAGF@pieU9+   743309960111HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF>@{omhXOF?(   743308960111HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF@{omhXOF?(   743307960105DATASCOPE PERCOR STAT DL 9.5 FR T.W. IABDATASCOPEDATASCOPE CORP.DEATH0684-00-0255NACARDIOVASCULARDSPFo@qm_XG<   743304960105CLEARTRACE CLEAR TAPE ADHESIVE GEL ELECTRODECONMEDCONMED CORP.SERIOUS INJURYNA1700-005CARDIOVASCULARDRXP@tjfVH@   743302960105FLEXICAIRHILLROMHILL-ROM, INC.DEATHMC3 M-4000NAGEN HOSPITALFNLF@nb`[MI=6&   743297960105WILSON SURGICAL FRAMEZIMMERPATIENT CARE DIV. ZIMMER, INC.SERIOUS INJURY551OPHTHALMICHRKF@ywrfaaQ1)   743296960105CAPSUREMEDTRONICMEDTRONIC, INC.DEATH4004NACARDIOVASCULARDTBF@k_]XHD>7&   743279960105CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2700NACARDIOVASCULARLWRF1@zsI@   743277960105KAZ HEAT PADKAZKAZ MANUFACTURINGSERIOUS INJURYNINIPHYS MEDIRTP@ma_ZPLH8%    743273960104ENDOPATH STEATH ENDOSCOPIC/CONVENTIONAL CIRCULAR SETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIECS25GEN & PLASTIC SURGERYGAGP@pTF   743272960104ENDOPATH BABCOCK GRASPERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIBB10GEN & PLASTIC SURGERYGCJP@pjfV:,   743271960105VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBCARDPACECARDIAC PACEMAKERS, INC.DEATH1625NACARDIOVASCULARLWSPY@{wqjPF   743263960106HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJP@{omhXOF?(   743262960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF@{omhXOF?(  4LVAL   8 l]b?$,jTHE IRRSKIN DISCOLORATION REPORTED WSKIN DISCOLORATION REPORTED WHERE ELECTRODES HAD BEEN. THE PT REPORTEDLY EXPIRED DUE TO STROKE, HYPOXEMIA AND CARDIAC ARREST. REPORTED A SECOND DEGREE BURN WHERE PAD HAD BEEN. HOSP ALLEGES ARC OCCURRED, RESULTING IN PT BURN IN AND AROUND PT'S MOUTH. BURNS WERE FIRST AND SECOND DEGREE. THE PT REPORTEDLY EXPIRED DUE TO INTESTINAL NECROSIS DUE TO LOW CARDIAC OUTPUT. NOT ENOUGH INFO AVAILABLE AT THIS TIME. REPORT OF INFANT DEATH BY HOMECARE DEALER. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. THE PT REPORTEDLY EXPIRED DUE TO RIGHT HEART FAILURE, AORTIC DISSECTION AND DISSEMINATING INTERVASCULAR COAGULATION. THE PT REPORTEDLY EXPIRED DUE TO CONGESTIVE HEART FAILURE. THE PT REPORTEDLY EXPIRED DUE TO SEPSIS, PULMONARY PNEUMONIA, DISSEMINATED INTRAVASCULAR COAGULATION AND RENAL FAILURE. THE PT REPORTEDLY EXPIRED DUE TO MULTIPLE SYSTEM FAILURE SECONDARY TO LOW OUT-PUT SYNDROME. THE VALVE WAS REPLACED DUE TO ALLEGED OUTLET STRUT FRACTURE. THE DEVICE WAS USED DURING A LEFT OOPHERECTOMY. THE DEVICE WOULD NOT FIRE ON THE THIRD FIRING. A SECOND DEVICE WAS FIRED, WHICH RESULTED IN MALFORMED STAPLES. IT WAS REPORTED THAT ONE DAY POSTOPERATIVELY, PT REQUIRED A REOPERATION FOR BLEEDING. THE DEVICE WAS USED DURING A LAPAROSCOPIC SIGMOID COLECTOMY. THE DEVICE WAS INSERTED THROUGH TROCAR AND APPLIED ON THE DISTAL RECTAL MARGIN AND FIRED; DEVICE WOULD NOT FIRE. SECOND ATTEMPT WITH FORCE APPLIED, WHICH RESULTED IN THE BREAKING OF HANDLE. A SECOND DEVICE WAS INTRODUCED AND FIRED WITHOUT DIFFICULTY. AFTER ANOTHER STAPLING DEVICE WAS TRANSANALLY INSERTED, IT WAS NOTED THAT THE RECTAL TISSUE BEYOND STAPLELINE WAS TORN AND SEVERELY DAMAGED. SURGEON CONVERTED TO AN OPEN PROCEDURE AND COMP LETED ANASTOMOSIS. THE DEVICE WAS USED DURING AN OVARIAN LIGAMENT PROCEDURE. THE DEVICE LOCKED ON TISSUE AND COULD NOT BE REMOVED. SURGEON CONVERTED TO AN OPEN PROCEDURE AND SURGICALLY REMOVED THE DEVICE FROM TISSUE. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. ON THIRD FIRING TO COMPLETE TRANSECTION OF THE RECTUM, NO STAPLES WERE FORMED, WHICH RESULTED IN LEAKAGE. A TEMPORARY ILEOSTOMY WAS PERFORMED. THE DEVICE WAS USED DURING A V.A.T.S./LUNG BIOPSY. IT WAS REPORTED THAT SURGEON PLACED DEVICE WITHIN PLEURAL SPACE AND WAS UNABLE TO CLOSE IT ON LUNG TISSUE TO FIRE. SURGEON ELECTED TO EXTEND INCISION AND COMPLETE PROCEDURE WITH A COMPETITOR'S DEVICE . THE DEVICE WAS USED DURING A TRANSVERSE COLECTOMY. THE DEVICE "DID NOT FEEL EXACTLY RIGHT" UPON FIRING. POSTOPERATIVELY, THE PT DEVELOPED A LOW-OUTPUT FISTULA. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO AN 82-YR-OLD MALE PT IN CARDIAC ARREST WHO WAS FOUND SUPINE IN THE LOBBY OF A BUILDING. THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECK THE PADS AND CABLES, BUT THE PR OMPTS WOULD NOT CLEAR. A BACK-UP EMS TEAM ARRIVED AND APPLIED THEIR DEFIBRILLATOR TO THE PT. THIS DEVICE DISPLAYED "CHECK ELECTRODES" PROMPTS. THE DEVICE WAS REMOVED FROM THE PT AND CPR WAS ADMINISTERED UNTIL THE PT WAS TRANSPORTED TO THE HOSP. THE H OSP ER PERSONNEL ASSUMED PT CARE. THE PT EXPIRED LATER IN THE ER. DURING AN INCIDENT CALL INVOLVING A 62 YR OLD PT IN CARDIAC ARREST, FIRE DEPT PERSONNEL WERE ON SCENE WHEN THE EMS TEAM ARRIVED. THE EMS TEAM ASSUMED PT CARE AND APPLIED THE DEVICE. THE DEVICE DELIVERED FOUR SHOCKS TO THE PT. THE 4TH DEVICE ASSESSMEN T REPORTEDLY RESULTED IN "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED THE PADS, CABLES, AND ALL OTHER COMPONENTS OF THE DEFIBRILLATOR, BUT THE PROMPTS WOULD NOT CLEAR. OPERATORS CONTINUED TO ADMINISTER CPR WHILE TRANSPORTING THE PT TO A HOSP. TH E PT WAS NOT RESUSCITATED.  LVAL y I _Kj>{ Sp2ONT PLAN "ENTER BEAM #1 AND ENTER A CUSTOMIZED PORT FOR THAT BEAM USING TABLE OR MOINTERNAL LAYER OF MATTRESS SEPARATED CAUSING A BUBBINTERNAL LAYER OF MATTRESS SEPARATED CAUSING A BUBBLE TO FORM UNDER THE PT. THERE WAS NO PT INJURY. THE PRODUCT BROKE DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE TUBING WAS SPLIT AND LEAKING BLOOD DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. HOSP REPORTED ONLY THAT "IT WAS FOUND TO BE DEFECTIVE." INTERNAL LAYER OF MATTRESS SEPARATED CAUSING BUBBLE TO FORM IN THE MATTRESS SURFACE. TEST CONFIRMS CELL SEPARATION. LUER LOCK CONNECTOR AND CATHETER SEPARATED AT A FLOW RATE OF 24 ML/DAY. SOME BLOOD LOSS RESULTED. BLOOD COLLECTION DEVICE WAS INSERTED INTO IV LINE AND IT BROKE AT THE HUB. CANNULA WAS REMOVED INTACT. THE INSERT FRACTURED WHILE IN THE PT'S MOUTH. THERE WAS NO INJURY. WHEELS FELL OFF FOUR OF CUSTOMER COTS. ADD'L SERIAL NUMBERS: L-296181, L-293319. ADD'L LOT NUMBER: M189990. THE COT FOLDED TO THE GROUND. ADD'L SERIAL NUMBERS: L-340214, L-340220. THE STOP COCK BROKE IN HALF DURING USE. NO PT INJURY OR TREATMENT. CAUTERY PENCIL WORKED INTERMITTENTLY. CAUTERY PENCIL WORKED INTERMITTENTLY. PARTICULATE MAY HAVE COME FROM THIS HANDPIECE DURING A PHACOEMULSIFICATION PROCEDURE. NO PT INJURY. RECEIVED CORRESPONDENCE FROM ATTY WHO STATED HIS CLINET'S WIFE WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME AND DIED. THE DEVICE WAS USED DURING A BOWEL PROCEDURE. POSTOPERATIVELY, THE PT DEVELOPED PERITONITIS AND EXPIRED. THE PT REPORTEDLY EXPIRED DUE TO ENDOCARDITIS AND STROKE. SKIN IRRITATION REPORTED AROUND THE ELECTRODE PLACEMENT SITE. NO FOLLOW-UP TREATMENT REQUIRED. THE TUBING SEPARATED FROM THE STOPCOCK DURING USE. THE PT'S PORT HAD TO BE RE-ACCESSED AS A RESULT OF THE SEPARATION. NO ADD'L TREATMENT WAS NECESSARY. WHEN REMOVING THE SHROUDED NEEDLE FROM THE IV SITE, BLOOD SPLASHED INTO THE NURSE'S EYE. THE PT'S MOTHER TESTED POSITIVE FOR HEPATITIS C. NO TREATMENT WAS ADMINISTERED. REPORT OF INFANT DEATH BY HOMECARE DEALER. MONITOR REPORTEDLY NOT IN USE AT TIME OF EVENT. DEVICE IS BEING RETURNED TO MFR FOR EVALUATION AND TESTING. THE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C004-10 AND 96-C005-10. THE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C004-10 AND 96-C006-12. THE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C005-10 AND 96-C006-12. A BALLOON WAS USED TO FURTHER DILATE A NEWLY DEPLOYED STENT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. DURING WITHDRAWAL OF THE BALLOON CATHETER, IT IS BELIEVED THE BALLOON CAUGHT THE PROXIMAL END OF THE STENT CAUSING THE STENT TO SLIP OUT OF THE PORTAL VEIN. CONTINUAL ATTEMPTS TO RE-ADVANCE THE BALLOON AND STENT WERE UNSUCCESSFUL. THE BALLOON AND SHEATH WERE REMOVED. REPORTEDLY, THE STENT MIGRATED TO THE RIGHT ATRIUM. AN ATTEMPT TO SNARE THE STENT WAS IN PROCESS WHEN THE PT ARRESTED. RESUSCITATIVE MEASURES WERE UNSUCCESSFUL AND THE PT SUBSEQUENTLY EXPIRED. CO INVESTIGATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT CONTINUES. THE DEVICE WAS DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. C O'S FOLLOW-UP INDICATED THIS DEVICE WAS BEING USED TO FURTHER DILATE A NEWLY DEPLOYED WALL STENT WITHIN THE PORTAL VEIN WHICH IS A NON-INDICATED USE OF THIS DEVICE. CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. dG U 4 Qrg"K 743502960115GORE-TEX STRETCH VASCULAR GRAFTWLGOREW.L. GORE & ASSOCIATES, INC.DEATHNANIGASTRO & UROLOGYMCIPt@zhd`Y;3   743467960108COMPAT ENTERAL FEEDING PUMPSANDNUTRSANDOZ NUTRITION CORP.DEATH199235199235GEN HOSPITALLZHP@}{vh`XQ9/   743466960110ROLLS 2000INVACAREINVACARE CORP.SERIOUS INJURY2018AD780NAPHYS MEDIORP@thfaWSH8(   743465960115SENSITIVE EYES DAILY CLEANERBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNINIOPHTHALMICLPNF@trma]YI:0   743464960115SENSITIVE EYES PLUS SALINE SOLUTIONBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNINIOPHTHALMICLPNF@{ythd`PA7   743463960110INTERPLAKBAUSLOMBBAUSCH & LOMB ORAL CARE ORGANIZATIONSERIOUS INJURYPB12NADENTALJEQF1@vtogc]M'   743461960109STORZ PREMIER MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT COMPANYSERIOUS INJURYDP2072NAOPHTHALMICHQEP@vrjZ@6   743460960109STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT COMPANYSERIOUS INJURYDP1603 200NAOPHTHALMICHQEP|@{wk[A7   743458960111INTRA-AORTIC BALLOON PUMPDATASCOPEDATASCOPE CORP.DEATHSYSTEM 97NACARDIOVASCULARDSPF2@vto_[PI8-   743455960110BURDICK DEFIBRILLATOR/MONITOR/RECORDERBURDICKBURDICK, INC.DEATHMEDI 5NACARDIOVASCULARLDDP@|zueaYRC:   743436960108PROSORBA COLUMNIMREIMRE CORP.SERIOUS INJURYNA10GASTRO & UROLOGYLQQF.@rfd_MIE5)#   743435960110YALE-NEW HAVEN CUSTOM ANESTHESIA SETMEDEXMEDEX, INC.SERIOUS INJURYNAMX6349-1GEN HOSPITALFPAP@}xj`\L?8   743434960106SHROUDED NEEDLE 20 GAMEDEXMEDEX, INC.SERIOUS INJURYNAMX920GEN HOSPITALFOZP@ymkfXQM=0)   743423960105GEMINI V/N VENTED W/CHECKVALVE, 2 VERSASAFE INJECTIMEDIMED CORP.DEATHNA2120GEN HOSPITALFPAP.@~|wic_XLF   743408960110BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500NAANESTHESIOLOGYFLSP@zxsc_YR9/   743407960108BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500NAANESTHESIOLOGYFLSF_@ zxsc_YR9/   743404960108CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2625DT6592CARDIOVASCULARLWRP{@ |tng=4   743402960105EDWARDS-DUROMEDICS BILEAFLET PROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH3160NACARDIOVASCULARLWQPA@ {unD;   743401960105CARPENTIER-EDWARDS PHYSIO RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4450NACARDIOVASCULARKRHP~@ vrle;2   743400960105CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2700NACARDIOVASCULARLWRPb@ zsI@   743399960105CARPENTIER-EDWARDS ANNULOPLASTY RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4500NACARDIOVASCULARKRHP@|xrkA8   743398960105CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625NACARDIOVASCULARLWRP@xtng=4   743397960105CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2625NACARDIOVASCULARLWRP@xtng=4  LVAL Q.DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILEDDURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILED TO IRRIGATE. IT WAS EXCHANGED FOR ANOTHER. NO PT INJURY. DURING SET UP PRIOR TO AN OPHTHALMIC PROCEDURE, THE TUBING WAS BLOCKED. NO REPRT OF PT INVOLVEMENT. THE CUTTER FAILED TO FUNCTION AND THAT ASPIRATION WAS EXTREMELY POOR. PROBLEMS WERE FOUND DURING SET UP. NO PT INVOLVEMENT. PENCIL WOULD ACTIVATE UPON DEPRESSING THE ROCKER SWITCH BUT WAS NOT OPERATING CONTINOUSLY. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. WHEN THE DEVICE WAS FIRED, THE SURGEON "FELT A CRUNCH WITH A BIT OF A CATCH." THE DONUTS LOOKED GOOD, HOWEVER, THE ANASTOMOSIS FELL APART. UPON INSPECTION, IT WAS NOTED THAT THE STAPLES HAD NOT FOR MED PROPERLY. A COLO-ANAL ANASTOMOSIS AND TEMPORARY DIVERTING COLOSTOMY WERE PERFORMED. DURING A CATARACT EXTRACTION PROCEDURE USING THIS OPHTHALMIC MICROSURGICAL SYSTEM, THE PHYSICIAN BROKE CAPSULE, PERFORMED A VITRECTOMY PROCEDURE, AND INSERTED AN ANTERIOR LENS. THE PHYSICIAN INDICATED THAT ASPIRATION SURGES FROM THIS SYSTEM MAY HAVE BEEN THE CAUSE FOR THE BROKEN CAPSULE AND THE SYSTEM WAS RETURNED FOR EVALUATION. THERE HAS BEEN NO REPORT OF ADD'L INJURY. THE UNIT DISPLAYED CONTINUOUS AUTOFILL FAILURE MESSAGES. THE PT EXPIRED. THE HOSP DOES NOT ATTRIBUTE THE DEATH OF THE PT TO THE PRODUCT. CO SVC ISOLATED AND REPLACED A DAMAGED PNEUMATIC MALE LUER FITTING. THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCT IONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. WHEN ATTEMPTING TO USE THE DEFIBRILLATOR ON A PT THE UNIT WOULD NOT CHARGE. IT WAS REPORTED THAT THE DR WAS PRESSING THE PEDAL DISCHARGE BUTTON WHILE THE NURSE WAS PRESSING THE CHARGE KEY ON THE UNIT. THE MESSAGE "SYSTEM ERROR" APPEARED ON THE DISPLA Y. ANOTHER DEFIBRILLATOR WAS IMMEDIATELY USED ON THE PT, PT DIED. THE CONTACT DECLINED TO GIVE OUT ANY FURTHER INFO ON THE PT OR THE EVENT. THE CONTACT DID NOT STATE THAT THE NEED TO USE ANOTHER DEFIBRILLATOR WAS RELATED TO THE DEATH OF THE PT. THE U NIT WAS REPORTEDLY TESTED BEFORE THE EVENT AND AFTER THE EVENT BY A THIRD PARTY SVC WITH NO PROBLEMS FOUND. THE "SYSTEM ERROR" APPEARED ON THE DISPLAY BECAUSE THE DR WAS PRESSING THE DISCHARGE BUTTON AT THE SAME TIME THE NURSE WAS PRESSING THE CHARGE KEY. THE TROUBLE SHOOTING GUIDE SECTION OF THE OPERATING INSTRUCTIONS MANUAL LISTED THIS ERROR MESSAGE AS A POSSIBLE RESULT OF THIS OPERATOR ERROR. THE DEVICE WILL NOT BE RETURNED TO THE FACTORY FOR FURTHER EVALUATION. AN ARTICLE IN THE JOURNAL ARCH DERMATOL./VOL.131, JUNE 1995, (PAGE 707: CASE 1), REPORTED A 66-YEAR-OLD MALE BEING TREATED FOR A NEUROLOGICAL CONDITION DEVELOPED LEUKOCYTOCLASTIC VASCULITIS APPROX 24 HOURS AFTER THE THIRD COLUMN TREATMENT. THE RASH W AS ACCOMPANIED BY FEVER AND ARTHRALGIA IN BOTH KNEES. THERE WERE NO NEW NEUROLOGIC, RESPIRATORY, OR GASTROINTESTINAL SYMPTOMS. NO FURTHER IMMUNOADSORPTION THERAPY WAS GIVEN. THE ERUPTION DISAPPEARED AFTER APPROX 7 DAYS, AND THE PT WAS DISCHARGED. LAB ORATORY TESTS ON ADMISSION REVEALED NORMAL ELECTROLYTE LEVELS, A HEMATOCRIT OF 0.41, A WHITE BLOOD CELL COUNT OF 11.4X109/L, AND A PLATELET COUNT OF 260X109/L. THE RESULTS OF LIVER FUNCTION TESTS WERE NORMAL. URINALYSIS REVEALED A PH OF 5.5, WITH 20 TO 50 RED BLOOD CELLS PER HIGH-POWER FIELD: THE FINDINGS WERE OTHERWISE UNREMARKABLE. THE ERYTHROCYTE SEDIMENTATION RATE WAS 52MM/H. THE PT WAS DIAGNOSED AS HAVING COLON CARCINOMA 5 YRS PRIOR TO ADMISSION. A LOW ANTERIOR RESECTION REVEALED DUKES' B2 STAGE COLON CARCINOMA. THE PT RECEIVED FLUOROURACIL AND RADIATION THERAPY AFTER SURGERY. IN 1991, APPROX 4.5 YEARS AFTER SURGERY, HE BECAME ATAXIC. LOW-TITER ANTI-PURKINJE'S CELL ANTIBODIES WERE FOUND IN HIS SCUM SAMPLE AND WERE BELIEVED TO BE THE CA USE OF HIS NEUROLOGIC DEGENERATION. DEVICE NOT RETURNED TO MFR. (*). {LVAL    I@|THE DEVICE WAS USED DURING A PNEUMONECTOMY. THE STAPLES DID NOT FORM AT THE TOP OF THE STAPLELINE, WHICH RESTHE DEVICE WAS USED DURING A PNEUMONECTOMY. THE STAPLES DID NOT FORM AT THE TOP OF THE STAPLELINE, WHICH RESULTED IN AIR LEAKAGE. PT WAS "NEAR DEATH", REQUIRING ANOTHER SURGEON TO BE CALLED IN TO SUTURE THE SITE. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO AN UNCONSCIOUS AND UNRESPONSIVE PT. REPORTEDLY, THE ALERT INDICATOR LIGHT FLASHED ON. THE PT WAS TRANSPORTED TO A HOSP AND WAS PRONOUNCED. THE COT FOLDED WHILE THE PT WAS ON THE COT, "CAUSING THE PT TO FALL BACKWARD. THE PT ALLEGES THAT THIS EVENT AGGRAVATED A PREVIOUS BACK INJURY." DURING AN INCIDENT CALL INVOLVING A 35-YR-OLD MALE PT IN CARDIAC ARREST, TWO SETS OF ELECTRODE PADS TORE WHEN THE OPERATORS ATTEMPTED TO REMOVE THE PROTECTIVE PLASTIC BACKING FROM THE PADS TO APPLY THEM TO THE PT. THE PT WAS TRANSPORTED TO A HOSP WHE RE HE EXPIRED. DURING AN INCIDENT CALL INVOLVING A 49-YR-OLD MALE PT IN CARDIAC ARREST, TWO SETS OF ELECTRODE PADS TORE WHEN THE OPERATORS ATTEMPTED TO REMOVED THE PROTECTIVE PLASTIC BACKING FROM THE PADS TO APPLY THEM TO THE PT. AN ALS TEAM THEN ARRIVED AND ASSUME D PT CARE WITH ANOTHER CO'S DEFIBRILLATOR. THE PT WAS TRANSPORTED TO A HOSP ER WHERE HE EXPIRED. THE GRAFT WAS PLACED IN THE LEG FOR ARTERIO-VENOUS ACCESS. A VCS CLIP SYSTEM WAS USED TO COMPLETE THE ANASTOMOSIS. TWELVE DAYS POSTOPERATIVELY, THE GRAFT REPORTEDLY TORE AT THE ANASTOMOSIS. THE PT REPORTEDLY DIED BECAUSE OF BLOOD LOSS. THE SURGEON DI D NOT IMPLICATE THE GRAFT AS THE CAUSATIVE FACTOR FOR THE PT DEATH, RATHER THE SURGEON IMPLICATED THE CLIP SYSTEM. A 98-YR-OLD SEMI COMATOSE RESIDENT WITH HISTORY OF DEMENTIA AND STROKE DISCONNECTED THE ENTERAL FEEDING ADMINISTRATION SET FROM THE FEEDING PUMP. THE PUMP WAS OFF, THEREFORE ALL ALARMS WERE DISARMED, AND THE ROLLER CLAMP ON THE ADMINISTRATION SET TUB ING WAS IN THE FULL OPEN POSITION. APPROX 700 CC OF FORMULA WAS DELIVERED TO THE PT IN 1.5 HRS. THE PT REPORTEDLY SHOWED SIGNS OF ASPIRATION AND WAS TAKEN TO THE HOSP. THE PT DIED APPROX 12 HRS LATER. A USER RECEIVED A CUT TO THE LEFT CALF DUE TO A SHARP EDGE ON THE FRONT OF A MANUAL WHEELCHAIR. THE REPORT STATES THE USER REQUIRED STITCHES. THE PATIENT WAS TREATED FOR "BILATERAL CORNEAL ABRASIONS" FOLLOWING USE OF THE PRODUCT AS PART OF THE LENS CARE REGIMEN. THE TREATING PHYSICIAN WAS UNSURE OF THE CAUSE OF THE CONDITION. THE PRODUCT WAS NOT RETURNED FOR TESTING. THE PATIENT WAS TREATED FOR "CORNEAL ABRASION" FOLLOWING USE OF THE PRODUCT AS PART OF THE LENS CARE REGIMEN. THE TREATING PHYSICIAN WAS UNSURE OF THE CAUSE OF THE CONDITION. THE PRODUCT WAS NOT RETURNED FOR TESTING. WHILE USING THE ELECTRIC TOOTHBRUSH A TOOTH BROKE. MALE PT IS 68 YRS OLD. THE DEVICE CONSISTS OF 3 COMPONENTS: BRUSH HEAD, POWER HANDLE, AND CHARGER BASE. ONLY THE POWER HANDLE AND CHARGER BASE WERE RETURNED. THESE COMPONENTS PASSED VISUAL AND PERFOR MANCE TESTING. THE BRUSH HEAD WAS NOT RETURNED. A REPORT WAS RECEIVED THAT INDICATED THIS FACILITY ATTEMPTED TO USE ANOTHER MFR'S BIFURCATED INTRAOCULAR PRESSURE DRIP CHAMBER ADAPTOR IN CONJUNCTION WITH ADD'L ACCESSORY COMPONENTS, USING A LUER TO LUER ADAPTOR. THE IRRIGATION AND VITRECTOMY CUTTER PNEUMATIC DRIVER LINES WERE REVERSED CAUSING ASPIRATION WITHOUT CUTTING POWER WHEN THIS OPHTHALMIC MICROSURGICAL SYSTEM WAS ACTIVATED. THIS RESULTED IN A DETACHED RETINA. THERE HAS BEEN NO REPORT OF ADD'L PT INJURY AS A RESULT OF THIS OPERATOR ERROR. THE CONTACT FOR THIS FACILITY HAS INDICATED THAT THIS PARTICULAR TYPE OF ADAPTOR HAS BEEN USED PREVIOUSLY WITHOUT INCIDENT AND HAS INDICATED THAT THE EQUIPMENT DID NOT MALFUNCTION. THE PT INJURY WAS THE DIRECT RESULT OF OPERATOR ERROR. ?c' & S 4p82C{AN ANESTHESIOLOGIST INTUBATE 744012960116CONMED ADULT REM GROUND PADCONMEDCONMED CORP.SERIOUS INJURYNA402-2204GEN & PLASTIC SURGERYGEIPSUPERFICIAL E.S. BURN. zcYUE7/   744009960116CEEONPHARMACIAOPHTHALMICS DIV. PHARMACIA, INC.SERIOUS INJURY810FOPHTHALMICHQLP@"{omh\\VF$   743972960112THREE WAY STOPCOCK WITH MALE LUER LOCKMEDEXMEDEX, INC.SERIOUS INJURYNAMX431-1LGEN HOSPITALFMGP@zlb^NA:   743971960112THREE WAY STOPCOCK WITH MALE LUER LOCKMEDEXMEDEX, INC.SERIOUS INJURYNAMX431-1LGEN HOSPITALFMGP@zlb^NA:   743970960112TRANSACT INTRA-AORTIC BALLOON PUMPCRBARDBARD VASCULAR SYSTEMS DIV. C.R. BARD, INC.DEATHNAH8000AILCARDIOVASCULARDSPF@!uqj>6   743958960116FIRST CHOICE BLOOD GLUCOSE REAGENT TEST STRIPSPOLYTECHCPOLYMER TECHNOLOGY INTERNATIONALSERIOUS INJURY91070CLINICAL CHEMISTRYCFRP @!oMB   743914960112SWAN-GANZ THERMODILUTION ATRIO-VENTRICULAR PACEPOREDWACVSEDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.DEATH93A-991H-8F93A-991H-8FCARDIOVASCULARDYGP@!OF   743894960112PROVIDER ONEABBOLABOABBOTT LABORATORIESDEATHNA13905 04 04GEN HOSPITALFRNF@ xljeWJF?*    743878960114LIFEPAK AUTOMATIC ADVISORY DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.DEATH300804900-03CARDIOVASCULARMKJP@ shc\F<   743868960115SIDERAILHILLROMHILL-ROM CO.DEATH301P301GEN HOSPITALFNLP@ fZXSE?:3%   743851960112CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625LPNACARDIOVASCULARLWRP@ wpF=   743846960112CARPENTIER-EDWARDS ANNULOPLASTY RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4400NACARDIOVASCULARKRHPV@|xrkA8   743748960111PALL CONSERVE HEAT & MOISTURE EXCHANGER WITH FLEXPALLBIOMPRODPALL BIOMEDICAL PRODUCTS CO.SERIOUS INJURYHME1522FNAANESTHESIOLOGYBYDF@ qSE   743747960110VANTAGECOOPERVISIONCOOPERVISION, INC.SERIOUS INJURYNANAOPHTHALMICLPLPd@thfaUQM=)   743744960109ISOLA 1/4" RODACROMEDACROMED CORP.SERIOUS INJURYNAUNKORTHOPEDICJDNP@rfd_SNJ:+"   743681960111LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.DEATH59-00285-08CARDIOVASCULARLDDP@usn^RPI3)   743583960109TRAMSCOPE PATIENT MONITORMARQELECMARQUETTE ELECTRONICS, INC.DEATHNANACARDIOVASCULARDRTF@zxsc_[T7-   743546960111COBE CENTRYSYSTEM 2COBERENACARECOBE RENAL CARE, INC.DEATHNA018701-002GASTRO & UROLOGYFIIF@|zucWSL5'   743513960112VASOSEAL VASCULAR HEMOSTASIS DEVICEDATASCOPECOLLAGEN PRODUCTS DIV. DATASCOPE CORP.DEATHNA75301GEN & PLASTIC SURGERYLMFF@|uqjB7   743510960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS2000900000CARDIOVASCULARMKJF@ymkfVNF?(   743509960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDFX@trm]UF?(   743508960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDF@trm]UF?(   743507960116HEARSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDFb@sql\TE>'  LVAL A FEMALE PT WAS ON THE WHOLE BODY TABLE HAVING A SPOT SCAN USING COLLIMATORS.THE TECHNOLOGIST (SGT. MARKLE) A PT RECEIVED A HEMOTHORAX DURING A CATHETER PLACEMENT PROCEDURE. REQUIRING BLOOD AND CHEST TUBE PLACEMENT. THE FACILITY NOTED IN THE REPORT THAT THE GUIDE WIRE WAS FOUND TO BE "UNWOUND" UPON REMOVAL. IN FOLLOW-UP WITH THE FACILITY, IT WAS LEARNED TH AT IT WAS ACTUALLY A PNEUMOTHORAX FOUND BY X-RAY. ACCORDING TO THE FACILITY, THE LEFT SUBCLAVIAN INSERTION WAS "VERY DIFFICULT" A PT RECEIVED A HEMOTHORAX DURING A CATHETER PLACEMENT PROCEDURE. REQUIRING BLOOD AND CHEST TUBE PLACEMENT. THE FACILITY NOTED IN THE REPORT THAT THE GUIDE WIRE WAS FOUND TO BE "UNWOUND" UPON REMOVAL. IN FOLLOW-UP WITH THE FACILITY, IT WAS LEARNED TH AT IT WAS ACTUALLY A PNEUMOTHORAX FOUND BY X-RAY. ACCORDING TO THE FACILITY, THE LEFT SUBCLAVIAN INSERTION WAS "VERY DIFFICULT" DUE TO THE PT'S LARGE SIZE. THE MFR'S ANALYSIS IS THAT THE GUIDEWIRE WAS NOT LIKELY THE CAUSE OF THE PNEUMOTHORAX. BUT BEC AME UNWOUND AS A SECONDARY EFFECT OF THE DIFFICULT PROCEDURE. PNEUMOTHORAX IS LISTED IN THE INSTRUCTIONS AS A POTENTIAL COMPLICATION OF A SUBCLAVIAN INSERTION AND IS A NORMAL RISK OF THE PROCEDURE. THE PT IS REPORTED AS FULLY RECOVERED FROM THE EVENT . THE OPERATIVE PROCEDURE WAS PLANNED PHACOEMULSIFICATION OF CATARACT WITH IOL IMPLANTATION. THE DR NOTED THAT HE NORMALLY IMPLANTS THIS LENS WITH NO PROBLEMS, HOWEVER, WHILE IMPLANTING THIS PARTICULAR LENS, HE NOTICED THAT ONE OF THE HAPTICS SEEMED TO "GRAB" THE POSTERIOR CAPSULE, AND PERFORATED THE BAG. THIS LENS WAS REMOVED, AND A SULCUS FIXATION IMPLANT WAS ACCOMPLISHED. AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. AT THE TIME OF THIS REPORT, THE PT IS DOING WELL VISUAL ACUITY IS 20/20. THE DR H AS REQUESTED THAT CO EXAMINE AND CHECK THE TECH SPECIFICATIONS FOR THIS LENS, WHICH IS BEING RETURNED FOR TECH ANALYSIS. THE RESULTS OF MFR BATCH CHECK ANALYSIS AND SUBJECT LENS EXAM ARE NOT YET AVAILABLE. ON 1/9/96 PT HAD PTCA PROCEDURE. HEMOSTASIS WAS ACHIEVED WITH CO'S DEVICE WITHOUT COMPLICATION. LATER THAT EVENING PT REPORTED TINGLING AND NUMBNESS IN THE VASCULAR HEMOSTASIS LEG. PT HAD A PULSE IN THE FOOT BUT BLOOD PRESSURE AND HEART RATE HAD DROP PED. PT WAS PUT ON A VENTILATOR. PHYSICIAN FELT THAT THESE COMPLICATIONS RESULTED FROM A RETROPERITONEAL BLEED CAUSED BY A DOUBLE WALL PUNCTURE. ON FOLLOW-UP (1/11/96) THE PT DIED. UNCONFIRMED CAUSE OF DEATH PER PHYSICIAN IS AN INFARCT. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO A 60-YR-OLD FEMALE PT WITH A HISTORY OF CARDIAC, EMPHYSEMA, ASTHMA, AND DIABETES WHO WAS IN CARDIAC ARREST. THE DEVICE REPORTEDLY DISPLAYED THE PT'S RHYTHM AS VENTRICULAR FIBRILLATION AND "CHECK ELEC TRODE" PROMPTS. THE OPERATORS CHECKED THE PADS AND CABLES, AND CHANGED THE PADS AND BATTERY, BUT THE PROMPTS WOULD NOT CLEAR. THE PT WAS NOT RESUSCITATED. DURING TESTING BY THE CUSTOMER AFTER THE INCIDENT, THE DEVICE REPORTEDLY AGAIN DISPLAYED "CHECK ELECTRODES" PROMPTS. DURING AN INCIDENT CALL INVOLVING A 67-YR-OLD MALE PT WEIGHING 300 LBS WHO WAS IN CARDIAC ARREST AND HAD BEEN DOWN APPROXIMATELY 15 MINUTES, A DEFIBRILLATOR WAS APPLIED USING ELECTRODE PADS. THE DEVICE WENT INTO THE MONITOR ONLY MODE. THE OPERATORS C HANGED THE PADS. THE PT WAS ASSESSED BY THE DEVICE AND WAS FOUND TO HAVE AN ASYSTOLIC RHYTHM. CPR WAS ADMINISTERED TO THE PT UNTIL AN ALS TEAM ARRIVED AND ASSUMED PT CARE. THE PT WAS TRANSPORTED TO A HOSP WHERE HE WAS PRONOUNCED. THE CUSTOMER STATED THAT THE DEVICE FUNCTIONED PROPERLY AND THAT HE BELIEVES THE FIRST SET OF PADS WERE NO GOOD. ;LVALX l zYPT DEATH. LOCAL DISTRICT ATTY AND MEDICAL EXAMINER OFFICE REQUESTED THAT CO CEASPT DEATH. LOCAL DISTRICT ATTY AND MEDICAL EXAMINER OFFICE REQUESTED THAT CO CEASE ITS INVESTIGATION UNTIL LOCAL LAW ENFORCEMENT COMPLETED ITS INVESTIGATION. THE DEVICE DISCONNECTED FROM ANOTHER MFR'S DEVICE DURING ECMO TREATMENT. AS A RESULT, THE PT EXPERIENCED SOME BLOOD LOSS REQUIRING A TRANSFUSION. THERE WAS NO ADD'L TREATMENT NECESSARY. THE DEVICE DISCONNECTED FROM ANOTHER MFR DEVICE DURING ECMO TREATMENT. AS A RESULT, THE PT EXPERIENCED SOME BLOOD LOSS REQUIRING A TRANSFUSION. THERE WAS NO ADD'L TREATMENT NECESSARY. PT WAS DISPENSED NEW SOFT CONTACT LENSES ON 11/29/95. PT WAS TREATED FOR AN ULCER OF THE LEFT EYE AT THE ER OF A LOCAL HOSP ON 12/25. THE ER PHYSICIAN HAD PRESCRIBED AN ANTIBIOTIC MEDICATION AND INSTRUCTED PT TO FOLLOW UP WITH AN EYE CARE PRACTITIONE R. PT WAS SEEN BY THE OPTOMETRIST ON 12/26/95. THE OD REPORTED THE ULCER WAS RESOLVING AND A MILD KERATITIS WAS ALSO NOTED. THE OD PRESCRIBED A LUBRICATING AGENT TO BE USED IN CONJUNCTION WITH THE ANTIBIOTIC MEDICATION. PT'S CONDITION HAS RESOLVED WI TH OUT COMPLICATION AND A NEW LENS HAS BEEN ORDERED. MALE PT IS 43 YRS OLD. DEVICE NOT RETURNED TO MFR. THE PT WAS INSTRUMENTED ON 6/23/94 WITH RODS AND RETURNED FOR REMOVAL OF FRACTURED ROD 12/19/95. AT EXPLANTATION, PT NOTED TO HAVE A SOLID FUSION. MALE PT IS 58 YRS OLD. DEVICE NOT RETURNED TO MFR. A LONG TERM FACILITY PT, WITH A HISTORY OF CARDIAC DISEASE, WAS CONNECTED TO THE DEVICE IN A DEFIBRILLATION ATTEMPT. THE PHYSICIAN PRESSED THE PADDLE CHARGE BUTTON, THE DEVICE CHARGED AND DELIVERED ENERGY TO THE PT. THE PHYSICIAN ALLEGED THE DEVICE D ID NOT DELIVER SELECTED DEFIBRILLATOR ENERGY TO THE PT. THIS ALLEGATION WAS BASED UPON A LACK OF EXPECTED PT DEFIBRILLATION AND AN OBSERVATION THAT THE DEVICE DID EMIT LOUD ENOUGH SOUNDS DURING CHARGE AND DISCHARGE. NO ADD'L DETAILS CONCERNING THE EV ENT WERE REPORTED. THE PT WAS NOT RESUSCITATED. SUBSEQUENT TO THE EVENT THE DEPT HEAD DISCHARGED THE DEVICE REPEATEDLY INTO A BATTERY SUPPORT SYSTEM AND OBSERVED THE DELIVERY OF SPECIFIED ENERGIES. A NON-INVASIVE BLOOD PRESSURE READING WAS OBTAINED ON A PULSELESS PT DURING A CODE. PT EXPIRED. CAUSAL RELATIONSHIP OF DEVICE TO THIS INCIDENT IS UNDETERMINED. A CHECK OF THE SYSTEM BY SERVICE REP FOUND DEVICE OPERATING NORMALLY. DURING A DIALYSIS TREATMENT, THERE WAS A PT DEATH AFTER THE DIALYSIS WITH STRAIGHT ACID CONCENTRATE. AN AUTOPSY WAS PERFORMED ON THE PT AND IT WAS FOUND A MYOCARDIAL INFARCTION WAS THE CAUSE OF DEATH. ANALYSIS: ACID ALONE WAS USED IN THE MACHINE AND THAT PRE-DIALYSIS CHECKS WERE NOT PERFORMED. THIS RESULTS IN METABOLIC ACIDOSIS DURING DIALYSIS BECAUSE NO BASE REPLACEMENT (BICARBONATE) IS ADMINISTERED DURING DIALYSIS. THIS ANALYSIS WAS CONFIRMED BY THE INVESTIGATOR FOR THE STATE DEPT OF HEALTH. R ECORDS REGARDING TREATMENTS, MACHINES USED, AND STAFF PRESENT WAS NOT AVAILABLE BECAUSE THESE RECORDS WERE REMOVED PRIOR TO THE INVESTIGATION BY THE STATE. THE OPERATOR MANUAL SPECIFICALLY WARNS THE OPERATOR NOT TO USE ACID CONCENTRATE IN THE MACHINE . ALTHOUGH THE CONDUCTIVITY FOR ACID OR ACETATE IS SIMILAR FOR CONDUCTIVITY MONITORING, THE OPERATOR MUST VERIFY THE CONDUCTIVITY AND PH OF THE CONCENTRATE PRIOR TO BEGINNING OF TREATMENT. THE PH MUST BE IN THE RANGE OF 6.5-8.0. IF THE PH IS INCORREC T, THE OPERATOR IS ADDITIONALLY PROMPTED TO VERIFY THAT THE CORRECT CONCENTRATE SOLUTION IS USED. THE PH OF THE ACID MIXED IN THE MACHINE IS APPROX 4.0 WHICH IS LOWER TH