BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1981216 · Received February 1, 2011

    Report

    Report Number
    3015876-2011-00090
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 7, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES WERE REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED PCB ASSEMBLIES AND VERIFIED THE REPORTED FAILURE; HOWEVER, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ITS SERVICE INDICATOR ILLUMINATED AND HAD A BLANK DISPLAY; HOWEVER, AFTER INITIAL EVALUATION, THE DEVICE WAS FOUND TO LOCK UP UPON BOOT UP. 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