BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTREAM XL

    MDR report key: 683932 · Received January 24, 2006

    Report

    Report Number
    683932
    Event Type
    Other
    Date Received
    January 24, 2006
    Date of Event
    January 23, 2006
    Report Date
    January 24, 2006
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL HAS HAD 3 REPORTED INSTANCES THAT THE DEFIBRILLATOR (LOCATED IN THE E.R.) WOULD NOT TURN ON WHEN AC POWER WAS REMOVED, AND THE BATTERY CHARGING LIGHT WOULD NOT ILLUMINATE WHEN THE POWER CORD WAS PLUGGED INTO THE WALL OUTLET. THESE INSTANCES OCCURRED WHEN THE DEFIBRILLATOR WAS BROUGHT BACK FROM TRANSPORT, NO PATIENTS WERE INVOLVED. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE BATTERY WAS PARTIALLY EJECTED. THIS IS MOST LIKELY DUE TO THE PLACEMENT OF THE CAMCORDER STYLE BATTERY AND ITS EJECT BUTTON, THAT IS LOCATED BELOW THE CARRYING HANDLE, WHICH CAN BE BUMPED, THUS PARTIALLY EJECTING THE BATTERY. THIS IS NOT READILY VISIBLE BY THE OPERATOR. THIS COULD POSSIBLY CAUSE A DELAY IN INTERVENTION. WE FEEL THAT THIS IS A MANUFACTURE DESIGN OVERSIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XL DEFIBRILLATOR MKJ AGILENT TECHNOLOGIES, INC. M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *