BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1894734 · Received November 5, 2010

    Report

    Report Number
    3015876-2010-01227
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A WHITE SCREEN AND LOCKED UP AT DIFFERENT TIMES. ON THE FIRST INSTANCE, THE FAILURE OCCURRED WHEN THE USER TURNED THE DEVICE ON TO CONNECT TO A PT. NORMAL DEVICE OPERATION WAS RESTORED AFTER POWER CYCLING THE DEVICE AND THERE WAS NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE. HOWEVER, ON A LATER OCCURRENCE WHEN THE USER ATTEMPTED TO PERFORM THE USER TEST, THE DEVICE LOCKED UP AND NORMAL OPERATION WAS NOT RESTORED AFTER TURNING THE DEVICE ON AND OFF. THERE WAS NO PT USE ASSOCIATED WITH THE SECOND 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 UNK