BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 1823264 · Received August 27, 2010

    Report

    Report Number
    1220908-2010-02339
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DEFIB OUTPUT WAS INCORRECT, MEASURING 456 JOULES WHEN SET AT 360 JOULES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA