BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 2860052 · Received October 31, 2012

    Report

    Report Number
    1220908-2012-02882
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL 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 TO TREAT A PATIENT. THE DEVICE CONTINUED TO PROMPT ¿REPLACE BATTERIES¿ MESSAGE WITH KNOWN GOOD BATTERIES AND THEN INAPPROPRIATELY SHUT DOWN. 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 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK