BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 1060368 · Received June 11, 2008

    Report

    Report Number
    1220908-2008-01243
    Event Type
    Death
    Date Received
    June 11, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 21, 2008
    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 MONITOR THE HEART RHYTHM OF A MALE PT WITH ELECTRODES PADS, THE DEVICE LOST ECG SIGNAL WHEN THE DEVICE AUTOMATICALLY SWITCHED TO LEADS-MODE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED; HOWEVER, IT WAS NOT RELATED TO THE REPORTED MALFUNCTION.

    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 40 YR Death