BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEWLETT PACKARD MODEL 43100A

    MDR report key: 22098 · Received April 27, 1995

    Report

    Report Number
    22098
    Event Type
    Death
    Date Received
    April 27, 1995
    Manufacturer
    HEWLETT PACKARD
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN VENTRICULAR FIBRILLATION PROGRESSING TO CARDIAC ARREST. DEFIBRILLATION ATTEMPTED AT 44 MINUTES INTO THE RESUSCITATION ATTEMPT. CO PLACE GEL ON PADDLES. PEDIATRIC PADDLES PLACED IN AA POSITION APPROX. 4 CM APART AT THE CLOSEST EDGES. CHARGED TO 300 JOULES AND DISCHARGED. A BRIGHT FLASH AND CRACKING NOISE OCCURRED. SECOND ATTEMPT WITH SAME RESULT. RESUSCITATION ATTEMPT ENDED AT 49 MINUTES. FAILURE TO DELIVER ENERGY TO THE PT IS NOT BELIEVED TO BE RELEVANT TO THE OVERALL FAILURE TO RESUSCITATE THIS PT. ANOTHER DEFIBRILLATOR WAS OBTAINED BUT NOT USED. UNIT CLEANED BY STERILE PROCESSING NOTED TO HAVE "A LOT OF GEL" ON THE PADDLES AND CONTROLS. DEFIBRILLATOR INSPECTED 4/18/95 BY HOSP CLINICAL ENGINEERING. NO RELATED PROBLEMS FOUND ALTHOUGH "PITTING" NOTED AT INNER ASPECTS OF PADDLES. UNABLE TO DETERMINE WHEN PITTING OCCURRED. UNIT INSPECTED AT HOSP BY CO ON 4/21/95. NO RELATED PROBLEMS FOUND. SUSPECT GEL BRIDGED LOCATION OF PADDLES CAUSING A MAJORITY OF ENERGY TO TRAVEL THROUGH THE GEL RATHER THAN INTO PT TISSUE.PT IN VENTRICULAR FIBRILLATION PROGRESSING TO CARDIAC ARREST. DEFIBRILLATION ATTEMPTED AT 44 MINUTES INTO THE RESUSCITATION ATTEMPT. GEL PLACED ON PADDLES. PEDIATRIC PADDLES PLACED IN AA POSITION APPROX 4 CM APART AT THE CLOSEST EDGES. CHARGED TO 300 JOULES AND DISCHARGED. A BRIGHT FLASH AND CRACKING NOISE OCCURRED. SECOND ATTEMPT WITH SAME RESULT. RESUSCITATION ATTEMPT ENDED AT 49 MINUTES. FAILURE TO DELIVER ENERGY TO THE PT IS NOT BELIEVED TO BE RELEVANT TO THE OVERALL FAILURE TO RESUSCITATE THIS PT. ANOTHER DEFIBRILLATOR WAS OBTAINED BUT NOT USED. UNIT CLEANED BY STERILE PROCESSING NOTED TO HAVE "A LOT OF GEL" ON THE PADDLES AND CONTROLS. DEFIBRILLATOR INSPECTED 4/18/95 BY HOSP CLINICAL ENGINEERING. NO RELATED PROBLEMS FOUND ALTHOUGH "PITTING" NOTED AT INNER ASPECTS OF PADDLES. UNABLE TO DETERMINE WHEN PITTING OCCURRED. UNIT INSPECTED AT HOSP BY MFR ON 4/21/95. NO RELATED PROBLEMS FOUND. SUSPECT GEL BRIDGED LOCATION OF PADDLES CAUSING A MAJORITY OF ENERGY TO TRAVEL THROUGH THE GEL RATHER THAN INTO PT'S TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD MODEL 43100A DEFIBRILLATOR/MONITOR LDD HEWLETT PACKARD 43100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death