BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 4963959 · Received July 30, 2015

    Report

    Report Number
    1220908-2015-01971
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION WAS DUPLICATED AND THE MAIN BOARD WAS REPLACED TO RESOLVE THE MALFUNCTION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL 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
    498114 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA