BEUDAMED
    FDA Adverse Event Death Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 2854950 · Received November 20, 2012

    Report

    Report Number
    1220908-2012-03171
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TREAT (B)(6) CYANOTIC MALE PT IN CARDIAC ARREST, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN FIRST ADJUSTED THE ORIGINAL ELECTRODE PAD PLACEMENT, THEN REPLACED THE CPR STAT PADS AND CONTINUED TREATING THE PT. COMPLAINANT INDICATED, THE PT RECEIVED DOSES OF EPINEPHIRNE, AND CPR WAS PERFORMED UNTIL HE WAS PRONOUNCED DEAD BY THE DOCTOR IN CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death