BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES OPERT DEFIBRILLATOR PAD

    MDR report key: 3820061 · Received May 15, 2014

    Report

    Report Number
    MW5036121
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZOLL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING SHOCK FOR SYNCHRONIZED ELECTIVE CARDIOVERSION FOR ATRIAL FIBRILLATION, STAFF HEARD A "POP" AND SAW A SPARK ON PT'S CHEST HAIRS WHICH CAUGHT FIRE. IMMEDIATELY EXTINGUISHED. SMALL REDDENED AREA ON 5X8 CM. PT ON BIPAP AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292390 X SERIES OPERT DEFIBRILLATOR PAD DEFIBRILLATOR MKJ ZOLL 760359 1014

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other METOPROLOL| OMEPROZOLE| FLUTICASONE NASAL SPRAY| AMLODIPINE| VITAMINS - DAILY FOR ALL MEDS