BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1171548 · Received September 17, 2008

    Report

    Report Number
    3015876-2008-01177
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL RECOMMENDED CUSTOMER REPLACING THE MAIN PCB BOARD ASSEMBLY AFTER OTHER FAILED ATTEMPTS TO REPAIR THE DEVICE. THE CUSTOMER LATER CONFIRMED THAT DUE TO THE REPAIRS COST, THE DEVICE HAS BEEN TAKEN OUT OF SERVICE AND WILL BE PROPERLY DISPOSED OF. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DOES NOT RESPOND TO CONTROLS AND DOES NOT GO THROUGH THE POWER ON BOOT UP. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA