BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 2946187 · Received January 2, 2013

    Report

    Report Number
    1220908-2012-03575
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL 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 WHILE TRANSPORTING A PT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THEY DIDN'T HAVE A SPARE BATTERY SO THEY OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK