BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3910257 · Received July 2, 2014

    Report

    Report Number
    3015876-2014-00756
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. AFTER EVALUATION AND AN ESTIMATION OF REPAIR COSTS, THE CUSTOMER HAS DECIDED NOT TO REPAIR THE DEVICE. THE CUSTOMER ALSO HAS REQUESTED THAT THE DEVICE BE RETURNED, UN-REPAIRED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING "SERVICE" ACROSS THE SCREEN AND THE DISPLAY WAS FLASHING. THIS IS AN INDICATION OF A DEVICE LOCK UP AND COULD NOT BE USED ON A PATIENT, IF NEEDED. THE DEVICE ALSO LOGGED AN EVENT CODE IN CORRELATION WITH THIS ISSUE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387086 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1