BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 1052164 · Received May 20, 2008

    Report

    Report Number
    1220908-2008-01028
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Report Date
    May 1, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY INTEGRATED CIRCUIT ON THE MAIN BOARD. TREND ANALYSIS FOR FAILURES OF THIS TYPE DOES NOT INDICATE AN INCREASE IN FREQUENCY.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA