BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 3952463 · Received May 14, 2014

    Report

    Report Number
    1220908-2014-01196
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE WAS UNABLE TO PACE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288284 PROPAQ MD DEFIBRILLATOR PROPAQ MD MKJ ZOLL MEDICAL CORPORATION PROPAQ MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA