BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 1771854 · Received July 22, 2010

    Report

    Report Number
    1220908-2010-01932
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 THE DEVICE WAS HOOKED UP TO A PT WITH STAT PADZ IN THE OFF POSITION AND AROUND 2AM, THE DEVICE PERFORMED A FULL 30J SELF TEST AND POSSIBLY DELIVERED THE 30J TEST SHOCK TO THE PT, WHOM THE NURSE OBSERVED JUMPED. THE NURSE SUBSEQUENTLY TURNED THE UNIT OFF. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. THE COMPLAINANT INDICATED THAT THE ORIGINAL STAT PADZ WERE THROWN OUT BUT WILL SEND IN A SAMPLE SET WITH THE DEVICE FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK