BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1027152 · Received April 9, 2008

    Report

    Report Number
    3015876-2008-00291
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    November 19, 2007
    Report Date
    March 11, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE MAIN 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 REPLACED PCB ASSEMBLY AND DETERMINED THAT ROOT CAUSE FOR THE OBSERVED MALFUNCTION WAS A SEVERELY DEPLETED ENERGY CELL IN AN IC CHIP, DESIGNATOR U28. DEVICE DATA STORAGE, INCLUDING DEFIBRILLATOR CALIBRATION CONSTANTS IS STORED IN A BATTERY-BACKED RAM CHIP, DESIGNATOR U28, ON THE MAIN PCB ASSEMBLY. IC CHIP U28 CONTAINS A LITHIUM ENERGY CELL BATTERY THAT CAN MAINTAIN THE DEVICE DATA FOR A MINIMUM OF FIVE YEARS CONTINUOUS DUTY. A RECENT FAILURE ANALYSIS HAS DETERMINED THAT A SEVERELY DEPLETED ENERGY CELL CAN RESULT IN A FAILURE OF THE DEFIBRILLATOR TO CHARGE COMPLETELY AND/OR A FAILURE TO DISCHARGE.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION/TESTING BY PHYSIO-CONTROL. PHYSIO-CONTROL WAS EVALUATING DEVICE AND OBSERVED THAT THE DEVICE LOCKS UP AND PACER TURNS ON AT POWER UP. FAULT CODE 22 WAS LOGGED INTO THE DEVICE ERROR LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA