BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3920212 · Received July 8, 2014

    Report

    Report Number
    3015876-2014-00778
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND OBSERVED THAT A CAPACITOR, DESIGNATOR C15 WAS NO LONGER SOLDERED TO THE PCB AND BECAME DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S DEVICE HAD LOGGED SEVERAL EVENT CODES. AFTER AN EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT A CAPACITOR HAD FALLEN OFF OF THE THERAPY PCB ASSEMBLY, WHICH PHYSIO DID CONFIRM WOULD AFFECT THE DEVICE'S ABILITY TO DELIVER DEFIBRILLATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398056 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1