BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 3873836 · Received June 3, 2014

    Report

    Report Number
    1220908-2014-01321
    Event Type
    Death
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    DSK
    PMA / PMN Number
    K011865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION 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 DEFIBRILLATE A PT (AGE AND GENDER UNK), THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE USING EXTERNAL PADDLES (SN # (B)(4)). 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
    324451 M SERIES DEFIBRILLATOR / PACEMAKER DSK ZOLL MEDICAL CORP. MSERIES CCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death