BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2221806 · Received August 17, 2011

    Report

    Report Number
    3015876-2011-00605
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U18, WHICH WAS FOUND TO BE THERMALLY SENSITIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT GO BEYOND THE START UP SCREEN. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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