BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3123329 · Received May 21, 2013

    Report

    Report Number
    3015876-2013-00414
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE INTERMITTENT FAILURE TO BE A BROKEN FRONT CASE ASSEMBLY STAND OFF FOR THE SPEAKER ASSEMBLY HOLD-DOWN SPRING. THE SPRING WAS ABLE TO MOVE FREELY AND CAUSING AN INTERMITTENT ELECTRICAL SHORT ON THE SYSTEM PCB ASSEMBLY. PHYSIO REPLACED THE FRONT CASE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE USER TEST. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WOULD INTERMITTENTLY FAIL TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224141 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1