BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDX FPIA ANALYZER

    MDR report key: 906952 · Received August 30, 2007

    Report

    Report Number
    1628664-2007-00403
    Event Type
    Other
    Date Received
    August 30, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 1, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    LCQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE TDX ANALYZER'S AIR HEATER, INSULATOR, THERMISTOR, FAN AND FAN FILTER. THE FAN AND AIR HEATER WERE FOUND TO BE CLOGGED/OBSTRUCTED. THE FSR ALSO PERFORMED A BOOM CALIBRATION, TEMPERATURE VERIFICATION, PHOTO CALIBRATION AND CHECKED AND ADJUSTED THE AIR SET FROM 33 TO 31. ALL THE CHECKS AND CALIBRATIONS PASSED AND THE INSTRUMENT WAS RETURNED TO THE CUSTOMER FOR OPERATION. THERE HAS BEEN NO FURTHER ISSUES DOCUMENTED. THE TDX SYSTEMS OPERATIONS MANUAL SECTION VI, TROUBLESHOOTING, DISPLAYED ERROR CODES, A H HTR BRK FAIL, PROVIDES ADEQUATE INSTRUCTION FOR THE CUSTOMER. A POSSIBLE CAUSE FOR THE ERROR IS THE AIR HEATER CONTINUES TO REMAIN ABOVE SPECIFICATION FOR A PERIOD OF TIME. THE CUSTOMER IS INSTRUCTED TO CONTACT THE CUSTOMER SUPPORT CENTER IMMEDIATELY. SECTION I, SYSTEM DESCRIPTION, OPERATIONAL PRECAUTIONS AND LIMITATIONS, INSTRUCTS THE OPERATOR TO KEEP THE ANALYZER OUT OF DIRECT SUNLIGHT, DRAFTS, AND AWAY FROM SOURCES OF DIRECT HEAT AND MOISTURE. THE EMERGENCY SHUTDOWN PROCEDURE INSTRUCTS THE OPERATOR TO TURN OFF THE ANALYZER, AND DISCONNECT THE POWER CORD PRIOR TO SERVICING. SECTION V, MAINTENANCE, WEEKLY, INSTRUCTS THE OPERATOR TO CLEAN THE AIR-FAN FILTER WEEKLY. THE INVESTIGATION DEMONSTRATED THAT THE TDX FPIA ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE TDX FPIA ANALYZER GENERATED ERROR CODE "A HTR BRK FAIL" ACCOMPANIED BY SMOKE AND A BURNING SMELL. THE INSTRUMENT WAS POWERED OFF AND UNPLUGGED. THE OPERATOR FOLLOWED THE EMERGENCY SHUTDOWN PROCEDURE. NO ONE WAS INJURED AND NO DAMAGE WAS DONE TO THE SURROUNDING ENVIRONMENT. THE CUSTOMER IS REQUESTING A SERVICE CALL. THERE IN NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDX FPIA ANALYZER AUTOMATED FPIA ANALYZER LCQ ABBOTT MANUFACTURING, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR