BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3912010 · Received July 3, 2014

    Report

    Report Number
    3015876-2014-00763
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE REMOVED SYSTEM PCB ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A THERMALLY SENSITIVE CRYSTAL, DESIGNATOR Y1 FROM THE SBC (SINGLE BOARD COMPUTER), LOCATED ON THE SYSTEM PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS INTERMITTENTLY NOT COMPLETING THE BOOT UP CYCLE. THE DEVICE WOULD ATTEMPT TO POWER ON, THEN ALL THE LIGHTS ON THE DEVICE WOULD FLICKER AND THE DEVICE WOULD LOSE POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389934 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1