BEUDAMED
    FDA Adverse Event Death Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 1240469 · Received November 20, 2008

    Report

    Report Number
    1220908-2008-02884
    Event Type
    Death
    Date Received
    November 20, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    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 WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER, IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death