BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1027122 · Received April 9, 2008

    Report

    Report Number
    3015876-2008-00292
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    December 18, 2007
    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
    KY, 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 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. PHYSIO-CONTROL RECOMENDED THE CUSTOMER REPLACE U28 AND RECALIBRATE THE DEVICE TO RESTORE PROPER OPERATION PHYSIO PROVIDED THE CUSTOMER WITH REPLACEMENT PART NUMBER AND REPAIR INFO. CUSTOMER LATER REPORTED THAT DEVICE WAS CRAPPED TO PURCHASE A BIPHASIC DEFIBRILLATOR THAT CONFORMED TO 2005 AHA GUIDELINES.

    Description of Event or Problem · 1

    FOUND WHILE TESTING. ACCORDING TO THE REPORTER, THE DEFIBRILLATOR CHARGES ONLY TO 70J FOR 200J TEST AND ENERGY SETTINGS WON'T CALIBRATE. NO PT USE WAS ASSOCIATED WITH THE REPORTED INCIDENT.

    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