BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1031687 · Received April 18, 2008

    Report

    Report Number
    3015876-2008-00353
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 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, 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 YRS 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. PHYSIO-CONTROL RECOMMENDED THE CUSTOMER REPLACE U28 AND RECALIBRATE THE DEVICE TO RESTORE PROPER OPERATION. PHYSIO PROVIDED THE CUSTOMER WITH REPLACEMENT PART NUMBER AND REPAIR INFORMATION.

    Description of Event or Problem · 1

    FOUND DURING TESTING ACCORDING TO THE REPORTER, THE DEVICE REAL-TIME CLOCK WOULD NOT KEEP TIME AND DEFIBRILLATOR ENERGY SETTINGS WOULD NOT CALIBRATE. THE REPORTER STATED THAT A 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