BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1953910 · Received December 15, 2010

    Report

    Report Number
    3015876-2010-01373
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE PROGRAMMED SYSTEM CONTROLLER PCB AND USER INTERFACE PCB ASSEMBLIES TO OBSERVE PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE SERVICE INDICATION AND LOGGED EVENT CODES IN THE MEMORY. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD LOCK UP AND RESET ITSELF CONTINUOUSLY. THERE WAS NO PT USE ASSOCIATED WITH THE 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