BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3953929 · Received July 23, 2014

    Report

    Report Number
    3015876-2014-00845
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE POWER PCB ASSEMBLY AND OTHER PARTS WHICH WERE DAMAGED BY A FAILURE WITH THE POWER PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO OBSERVED HEAVY BURN DAMAGE TO THE POWER PCB ASSEMBLY BUT WAS UNABLE TO DETERMINE A COMPONENT CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEY SMELLED AN ELECTRICAL BURNING SMELL AND THEIR DEVICE WOULD NOT POWER ON. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS OF THE PATIENT EVENT. THERE WAS NO REPORT OF ANY ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431434 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1