BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE

    MDR report key: 757384 · Received July 27, 2006

    Report

    Report Number
    3002807968-2006-00037
    Event Type
    Malfunction
    Date Received
    July 27, 2006
    Date of Event
    June 23, 2006
    Report Date
    July 26, 2006
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LNX
    PMA / PMN Number
    k050869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SOFTWARE DEFECT IS CORRECTED WITH A SOFTWARE UPGRADE. SEE OUR CORRECTION AND REMOVAL REPORT 3002807968-7/13/2006-003-C. ADD'L CATLOG # 914-426.

    Description of Event or Problem · 1

    RADIANCE IS USED AS A DATA EXCHANGE AND PROCESSING INTERFACE BETWEEN A BLOOD GAS ANALYZER AND THE HOSPITAL OR LABORATORY INFORMATION SYSTEM (HLIS). IF THE FRACTION OF INSPIRED OXYGEN (FIO2) IS EDITED (EITHER IN MANUAL SAMPLE PROCESSING MODE) OR ON AN EXISTING RESULT, THE CHANGES NOT REFLECTED IN RADIANCE INSTRUMENT MANAGEMENT ENGINE (RIME) AND CONSEQUENTLY THE RESULT IS TRANSMITTED TO HLIS WITH THE OLD AND NOW WRONG VALUE. THIS MAY RESULT IN INCORRECT BLOOD GAS MEASUREMENTS BEING TRANSMITTED TO HLIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE LABORATORY INFORMATION MANAGEMENT SYSTEM LNX RADIOMETER MEDICAL APS RADIANCE V2. 60 *

    Patients

    Seq Age Sex Outcome Treatment
    1