BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 2023814 · Received February 14, 2011

    Report

    Report Number
    1220908-2011-00385
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE TREATING A (B)(6) FEMALE PT, THE DEVICE CHARGED ENERGY TO 120 JOULES, AND THEN THE DISPLAY BLANKED OUT. THE ENERGY WAS SUCCESSFULLY DELIVERED THE ENERGY WAS CHARGED A SECOND TIME TO 200 JOULES, AND THE DISPLAY BLANKED OUT. THE ENERGY WAS SUCCESSFULLY DELIVERED. 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
    1 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR