BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR

    MDR report key: 34146 · Received July 15, 1996

    Report

    Report Number
    MW1009487
    Event Type
    Malfunction
    Date Received
    July 15, 1996
    Report Date
    June 27, 1996
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A PM OF UNIT IT WAS DISCOVERED THAT WHEN THE BATTERY IS AT LOW LEVEL (BUT WITHIN RANGE OF PERFORMANCE) AND INDICATOR IS MOVED PAST THE 30 JOULE SETTING IT WILL CHARGE UP TO 30 JOULES AUTOMATICALLY WITHOUT PRESSING CHARGE BUTTON. THIS SITUATION DOES NOT HAPPEN WHEN UNIT IS PLUGGED IN WALL OUTLET OR WITH FULLY CHARGED BATTERY. WHEN THIS SITUATION OCCURS AN INADVERTENT SHOCK COULD BE DELIVERED TO PT OR OPERATOR. BIOMED TESTED THREE OF FIVE DEFIBRILLATORS AND ALL THREE HAVE THAT SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR DEFIBRILLATOR LDD HEWLETT-PACKARD CO. HP 43100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO