BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 2961057 · Received January 16, 2013

    Report

    Report Number
    1220908-2013-00074
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINANT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR, A PEDIATRIC PT, DURING MED FLIGHT TRANSPORT, THE DEVICE SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORT MALFUNCTION. PLEASE REFERENCE MDR# 1220908-2013-00075 FOR A SIMILAR REPORT WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24114 PROPAQ MD DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION PROPAQ MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK