BEUDAMED
    FDA Adverse Event Death Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 294931 · Received September 8, 2000

    Report

    Report Number
    1220908-2000-00920
    Event Type
    Death
    Date Received
    September 8, 2000
    Date of Event
    August 13, 2000
    Report Date
    August 13, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A PT IN CARDIAC ARREST, THE MEDICS WERE UNSURE IF THE DEVICE WAS FUNCTIONING. THE PT HAD "BEEN DOWN" ROUGHLY 15 MINUTES BEFORE THERAPY BEGAN, AND WAS DAMP FROM BEING AT SEA ON A BOAT. THERAPY WAS INITIATED ON THE DOCKED BOAT AND THE MEDICS WERE UNABLE TO SEE ANY VISIBLE TWITCHING OF THE PT TO INDICATE THAT THE DEVICE WAS PACING THE PT. HOWEVER, THE DEVICE APPEARED TO RESPOND TO ALL INPUT AND NO ERROR MESSAGES WERE SEEN. THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death