BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1024180 · Received March 26, 2008

    Report

    Report Number
    3015876-2008-00221
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    January 11, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY, AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER INVESTIGATED THE REPLACED ASSEMBLY, AND DETERMINED THAT THE ROOT CAUSE FOR THE REPORTED FAILURE WAS DUE TO A TEMPERATURE SENSITIVE IC CHIP U18.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD INTERMITTENTLY DISPLAY A WHITE/GREY SCREEN. 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