BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 3784492 · Received March 21, 2014

    Report

    Report Number
    1220908-2014-00644
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORP 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 WHILE ATTEMPTING TREATING A PT (AGE & GENDER UNK), THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170567 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK