BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1003248 · Received February 21, 2008

    Report

    Report Number
    3015876-2008-00078
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED FAULT CODES RELATED TO DEFIBRILLATION LOGGED INTO DEVICE MEMORY AND THAT IT WOULD NOT RECOGNIZED WHEN A THERAPY CABLE WAS CONNECTED TO IT. PHYSIO REPLACED THE THERAPY AND BIPHASIC PCB ASSEMBLIES, AND THEN OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE'S SVC LED ILLUMINATED AND IT WOULD NOT RECOGNIZE THAT THE HANDS FREE DEFIBRILLATION THERAPY CABLE WAS CONNECTED TO IT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AS A RESULT OF THE DEVICE USE.

    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 UNK