BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 791333 · Received November 30, 2006

    Report

    Report Number
    1220908-2006-02503
    Event Type
    Death
    Date Received
    November 30, 2006
    Report Date
    November 7, 2006
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS REC'D 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 DEFIBRILLATE A PT (AGE & GENDER UNK) THE DEVICE DISPLAYED A "DISCHARGE ERROR" MESSAGE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION M SERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death