BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2234150 · Received August 31, 2011

    Report

    Report Number
    3015876-2011-00644
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED A CRITICAL FAULT CODE LOGGED IN THE SERVICE MEMORY, THEN REPLACED THE THERAPY PCB ASSEMBLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE THERAPY PCB ASSEMBLY WAS DISPOSED OF AND WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. A CLINICAL EVALUATION OF THE REPORTED EVENT WAS PERFORMED AND DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT BECAUSE DEFIBRILLATION THERAPY WAS DELAYED GREATER THAN 30 SECONDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT INCIDENT, THE DEVICE WAS CHARGED UP AND DELIVERED ONE SUCCESSFUL DEFIBRILLATION SHOCK; HOWEVER AFTER THE INITIAL SHOCK, THE END USER ATTEMPTED TO CHARGE THE DEFIBRILLATION ENERGY ONCE AGAIN, BUT THE SERVICE LIGHT ILLUMINATED AND THE DEVICE WOULD NO LONGER PROPERLY CHARGE DEFIBRILLATION ENERGY. A BACK-UP DEVICE WAS BROUGHT IN APPROXIMATELY FOUR (4) MINUTES LATER AND DELIVERED AN ADDITIONAL 8 DEFIBRILLATION SHOCKS. AT THAT POINT, THE HOSPITAL STAFF DECIDED TO CEASE FURTHER DEFIBRILLATION SHOCKS AND CPR. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death