BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3250534 · Received July 26, 2013

    Report

    Report Number
    3015876-2013-00668
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 4, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT THEN REPLACED THE USER INTERFACE AND SYSTEM CONTROLLER PCB ASSEMBLIES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AFTER REPAIR, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    A THIRD-PARTY SERVICE AGENT RECEIVED A CUSTOMER'S DEVICE FOR SERVICE AND OBSERVED THAT THE DEVICE HAD A WHITE, FROZEN DISPLAY WHEN THE DEVICE WAS SWITCHED ON. THIS IS INDICATIVE OF A DEVICE LOCK-UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350312 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1