BEUDAMED
    FDA Adverse Event Death Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 1243963 · Received November 25, 2008

    Report

    Report Number
    1220908-2008-02835
    Event Type
    Death
    Date Received
    November 25, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP 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 CLINICIANS RESPONDED TO A CALL FOR A 45-YEAR-OLD MALE PT INVOLVED IN A CAR ACCIDENT. AFTER MONITORING THE PATIENT'S HEART RHYTHM, THE PATIENT WAS DEFIBRILLATED. COMPLAINANT ALLEGED THAT WHILE REVIEWING THE SUMMARY REPORT OF THE EVENT, IT WAS OBSERVED THAT THE DEVICE WAS SET TO DELIVER AT 120 JOULES, AND DELIVERED AT 164 JOULES. THE DEVICE THEN DID NOT AUTO-ESCALATE TO 150 JOULES, HOWEVER, IT STAYED AT 120 JOULES AND DELIVERED AT 163 JOULES. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE MALFUNCTION WAS NOT ABLE TO BE DUPLICATED.

    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 45 YR Death