BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 3161682 · Received May 31, 2013

    Report

    Report Number
    1220908-2013-01158
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (B)(6) MALE PT THE DEVICE WAS UNABLE TO DISCHARGE USING CPR ELECTRODE STAT PADS. THE DEVICE INITIALLY DISCHARGED THE FIRST 4 TIMES. HOWEVER, THE CLINICIAN HAD TO PRESS THE DISCHARGE BUTTON MULTIPLE TIMES ON THE 5TH AND 6TH ATTEMPT BEFORE A SHOCK WAS DELIVERED. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED. FURTHER TESTING WITH A SIMULATOR, THE DEVICE DISCHARGED MULTIPLE TIMES SUCCESSFULLY. THE COMPLAINANT INDICATED THAT THE CPR STAT PADS INVOLVED IN THE REPORTED MALFUNCTION WERE NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240649 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death