BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 556637 · Received November 24, 2004

    Report

    Report Number
    1220908-2004-02391
    Event Type
    Death
    Date Received
    November 24, 2004
    Date of Event
    October 27, 2004
    Report Date
    November 1, 2004
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSGE. COMPLAINANT INDICATED THAT KIMBERLY CLARK ELECTRODES WERE USED IN CONJUNCTION WITH THE DEVICE. THE CLINICIAN MADE THREE ATTEMPTS TO DELIVER THERAPY AND WAS SUCCESSFUL TWO OF THE THREE TIMES. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED. PLEASE REFER TO REPORTS 1220908-2004-02390 & 1220908-2004-02460 IN WHICH THE COMPLAINANT REPORTED SIMILAR ALLEGED MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP. MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death