BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2800122 · Received October 22, 2012

    Report

    Report Number
    3015876-2012-00782
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 25, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE BIPHASIC PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U12.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE CUSTOMER'S DEVICE HAD ITS SERVICE INDICATOR ILLUMINATED AND HAD LOGGED AN EVENT CODE. AFTER FURTHER EVALUATION, IT WAS OBSERVED THAT THE CUSTOMER'S DEVICE WOULD NOT HAVE BEEN ABLE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1