BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1013263 · Received March 14, 2008

    Report

    Report Number
    3015876-2008-00185
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    October 17, 2007
    Report Date
    October 17, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED PCS ASSEMBLY, BUT COULD NOT REPLICATE LOCK-UP CONDITION THAT WAS PREVIOUSLY OBSERVED. THE EVALUATION DID DETERMINE THAT ROOT CAUSE FOR PREMATURE CHARGE DEPLETION OF THE COIN CELL BATTERY WAS DUE TO AN ELECTRICALLY LEAKY NVRAM CHIP.

    Description of Event or Problem · 1

    DEVICE WAS ORIGINALLY REPORTED THAT IT COULD NOT KEEP TIME AND DATE AND FAULT CODES WERE LOGGED INTO THE ERROR LOG THAT RELATED TO LOST CONFIGURATIONS DUE TO A CHARGE DEPLETED COIN CELL BATTERY. PHYSIO-CONTROL REPLACED THE COIN CELL BATTERY. SOMETIME LATER, WHEN THE DEVICE WAS POWERED ON, THE DEVICE LOCKED UP AND THE FRONT PANEL CONTROLS WERE NOT OPERATIONAL. 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