BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1000578 · Received February 15, 2008

    Report

    Report Number
    1220908-2008-00254
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY INSULATED GATE BI-POLAR TRANSISTOR ON THE BRIDGE BOARD.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA