BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1062242 · Received June 17, 2008

    Report

    Report Number
    3015876-2008-00613
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED MULTIPLE OCCURRENCES OF A FAULT CODE LOGGED INTO DEVICE MEMORY RELATED TO DEVICE RECOGNITION OF PADDLES CONNECTED OR THE DEVICE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WILL NOT RECOGNIZE PADDLES CONNECTED AND HAS AN ILLUMINATED SERVICE INDICATOR. THERE WAS NO PATIENT 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