BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 2943426 · Received January 8, 2013

    Report

    Report Number
    1220908-2012-03611
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 26, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORPORATION HAS REC'D 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 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
    10251 PROPAQ MD DEFIBRILLATOR DEFIBRILATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION PROPAQMD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA