BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1894200 · Received November 3, 2010

    Report

    Report Number
    3015876-2010-01210
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. THE THERAPY RECEPTACLE CONNECTOR ASSEMBLY WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. ALSO, THE POWER SUPPLY ASSEMBLY WAS REPLACED TO REPAIR THE REPORTED BROKEN STUD. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WILL INTERMITTENTLY NOT RECOGNIZE THE TEST PLUG OR HARD PADDLES FOR THE DAILY TEST. IT WAS ALSO INDICATED THAT THE GROUND STUD WAS BROKEN OFF ON THE BACK OF THE POWER SUPPLY MODULE. 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