BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2133257 · Received May 11, 2011

    Report

    Report Number
    3015876-2011-00381
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPORTED THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES 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 AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U61.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A FROZEN DISPLAY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVAL BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE ENTIRE DEVICE WAS LOCKED-UP AND WOULD NOT FUNCTION AT ALL WHEN IN THIS STATE.

    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