BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1070732 · Received July 2, 2008

    Report

    Report Number
    3015876-2008-00744
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN CONTROL KEYPAD ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND OBSERVED THAT METALLIC MATERIAL FROM THE DOME SWITCH HAD RUBBED OFF ON THE PCB LAYER AND WAS INTERMITTENTLY ACTIVATING THE SWITCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT POWERED OFF THREE TIMES DURING THE SERVICE REPORT DOWNLOADS. THE "ON" SEEMED INTERMITTENT. THERE WAS NO PT USE ASSOCIATED WITH THIS INCIDENT.

    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