BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 4652974 · Received March 27, 2015

    Report

    Report Number
    1220908-2015-00704
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Report Date
    March 10, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K972241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORP AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE BATTERY INVOLVED WAS NOT RETURNED TO ZOLL MEDICAL CORP AS PART OF THIS INVESTIGATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TREATING A PT (AGE & GENDER UNK), THE DEVICE'S DISPLAY BLANKED OUT AFTER DEFIBRILLATION THE PT AT 200 JOULES. 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
    204959 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION M SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK