BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 1830170 · Received September 1, 2010

    Report

    Report Number
    1220908-2010-02375
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "STATUS 44" AND "STATUS 101" 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 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA