BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2050035 · Received April 1, 2011

    Report

    Report Number
    1220908-2011-00856
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND WAS ATTRIBUTED TO A FAULTY INTEGRATED CIRCUIT ON THE SYSTEM BOARD. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. 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