BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1400 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1810945 · Received August 9, 2010

    Report

    Report Number
    1220908-2010-02125
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO CHARGE ENERGY. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD1400 DEFIBRILLATOR/PACEMAKER DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION PD1400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA