BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 1002972 · Received February 22, 2008

    Report

    Report Number
    1220908-2008-00359
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A FEMALE PT, THE DEVICE PROMPTED "STAND CLEAR", HOWEVER, DID NOT PROCEED WITH A "SHOCK ADVISED" PROMPT AND MEDICS WERE UNABLE TO DELIVER THERAPY. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. 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 MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death