BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2043592 · Received March 29, 2011

    Report

    Report Number
    3015876-2011-00278
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED PCB ASSEMBLIES AND FOUND THE CAUSE OF THE REPORTED FAILURE TO BE AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U2 FROM THE USER INTERFACE PCB ASSEMBLY WHICH WAS HEAT SENSITIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD LOCK UP WHEN POWERED ON AND DISPLAY A WHITE SCREEN. THERE WAS NO PATIENT 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