BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 970866 · Received December 28, 2007

    Report

    Report Number
    1220908-2007-02847
    Event Type
    Death
    Date Received
    December 28, 2007
    Date of Event
    December 11, 2007
    Report Date
    December 11, 2007
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WHILE ATTEMPTING TO TREAT A PT (AGE & GENDER UNK) AFTER 6 SUCCESSFUL DISCHARGES, THE DEVICE FAILED TO DISCHARGE ON THE 7TH ATTEMPT. 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 CCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death