BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2841963 · Received November 21, 2012

    Report

    Report Number
    3015876-2012-00850
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 26, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS ADVISED PHYSIO-CONTROL THAT THEY WOULD NOT LIKE TO REPAIR THE DEVICE DUE TO THE AGE AND COSTS ASSOCIATED WITH REPAIR. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DISPLAY ON THE DEVICE WAS NOT FUNCTIONAL. AFTER AN EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE REPEATEDLY LOGGED AN EVENT CODE AND WAS EXHIBITING A LOCK-UP FAILURE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1