BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 1964867 · Received December 23, 2010

    Report

    Report Number
    1220908-2010-03640
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP 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 ATTEMPTING TO TREAT A PT, THE DEVICE FAILED TO CHARGE TO SET ENERGY AND THE DISPLAY BLANKS OUT. COMPLAINANT DID NOT INDICATED 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
    1 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK