BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 2887699 · Received December 19, 2012

    Report

    Report Number
    1220908-2012-03503
    Event Type
    Death
    Date Received
    December 19, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DSK
    PMA / PMN Number
    K011865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, THE DEVICE FAILED PACE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER DSK ZOLL MEDICAL CORPORATION MSERIES CCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death