BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1028013 · Received April 10, 2008

    Report

    Report Number
    3015876-2008-00316
    Event Type
    Malfunction
    Date Received
    April 10, 2008
    Date of Event
    January 10, 2008
    Report Date
    March 11, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED IC CHIP, DESIGNATOR U28, ON THE MAIN PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. 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 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.

    Description of Event or Problem · 1

    FOUND DURING REGULAR INSPECTION AND TESTING. PHYSIO-CONTROL OBSERVED THAT THE DEVICE DISPLAYS A SERVICE INDICATOR WHEN POWERING UP, AN "ENERGY FAULT" WARNING MESSAGE WHEN THE CHARGE BUTTON WAS PRESSED, AND A FAULT CODE 22 WAS LOGGED INTO THE DEVICE ERROR LOG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA