BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 1903593 · Received November 16, 2010

    Report

    Report Number
    1220908-2010-03254
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    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 FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SEE ATTACHMENT