BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1011911 · Received March 10, 2008

    Report

    Report Number
    3015876-2008-00156
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    December 12, 2007
    Report Date
    January 22, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE SERVICE INDICATOR WAS PERSISTENTLY ILLUMINATED AND FAULT CODES RELATED TO DEFIBRILLATION WERE LOGGED INTO THE DEVICE'S ERROR LOG. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND THEN OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED THERAPY PCB ASSEMBLY AND OBSERVED THAT, WITH THE ASSEMBLY IN A DEVICE MOCK-UP, THE MOCK-UP DEFIBRILLATOR WOULD NOT DELIVER SELECTED ENERGY. ROOT CAUSE WAS DETERMINED TO BE AN IC CHIP, DESIGNATOR U34.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SERVICE INDICATOR WAS ILLUMINATED ON THE DEVICE FRONT PANEL AND WOULD NOT GO OUT EVEN AFTER THE DEVICE WAS POWERED OFF THEN ON AGAIN. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA