BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1147472 · Received August 21, 2008

    Report

    Report Number
    3015876-2008-00991
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 23, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DATA STORAGE, INCLUDING DEFIBRILLATOR CALIBRATION CONSTANTS, ARE 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 5 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. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING SERVICE ERRORS 22 AND 40. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.

    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