BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1082787 · Received July 24, 2008

    Report

    Report Number
    3015876-2008-00832
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 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 EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM/MEMORY PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REPLACED ASSEMBLY DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS DUE TO CORRUPTED MEMORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRANSPORTING A PATIENT WITH SEVERE RESPIRATORY DISTRESS FROM ONE HOSPITAL TO ANOTHER, THE DEVICE'S SCREEN WENT BLANK AND STARTED FLASHING THE WORD "SERVICE". ALSO, ALL OF THE LED LIGHTS ON THE FUNCTION BUTTONS BEGAN TO FLASH. THE MONITOR WAS TURNED OFF AND TURNED BACK ON WITH THE SAME RESULTS. THE PATIENT WAS THEN PLACED ON ANOTHER DEVICE AND MONITORED USING THAT DEVICE FOR THE REST OF THE FLIGHT. THERE WAS NO DIRECT EFFECT ON THE PATIENT OR PATIENT CARE AS A RESULT OF THIS FAILURE.

    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