BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3954707 · Received July 24, 2014

    Report

    Report Number
    3015876-2014-00847
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP INFORMATION: PHYSIO-CONTROL EVALUATED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A CRYSTAL, DESIGNATOR Y1 ON THE SINGLE BOARD COMPUTER (SBC) OF THE SYSTEM PCB ASSEMBLY WHICH INTERMITTENTLY STOPPED OSCILLATING. THIS CAUSED A NO BOOT-UP SITUATION. DURING TESTING WITH ANOTHER SBC INSTALLED, THE SYSTEM PCB ASSEMBLY FUNCTIONED PROPERLY.

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT REPLACED THE SYSTEM PCB ASSEMBLY. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. FOLLOWING REPAIR, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT THEIR DEVICE DID NOT COMPLETE ITS BOOT CYCLE DURING THE DAILY MORNING CHECK. THE DEVICE'S AUXILIARY POWER, BATTERY CHARGING AND SERVICE INDICATOR LEDS FLASHED. THE ON BUTTON'S LED FLASHED AS WELL. THE DEVICE'S DISPLAY WAS ON, BUT FAINTLY. AFTER A FEW SECONDS THE DEVICE POWERED OFF AUTOMATICALLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433816 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1