BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3081506 · Received April 29, 2013

    Report

    Report Number
    3015876-2013-00338
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL REPLACED THE SYSTEM PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REMOVED SYSTEM PCB ASSEMBLY DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE A FAILED TEMPERATURE SENSITIVE CRYSTAL, DESIGNATOR Y1, ON THE SINGLE BOARD COMPUTER (SBC).

    Description of Event or Problem · 1

    DURING A SCHEDULED INSPECTION, PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WOULD INTERMITTENTLY FAIL TO POWER ON. THE DEVICE INITIALLY POWERED ON AND PASSED THE USER TEST BUT IT FAILED TO POWER ON LATER AFTER BEING TURNED OFF FOR APPROXIMATELY 10 SECONDS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185107 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1