BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI GXL 6 SLICE PET/CT SYSTEM

    MDR report key: 920287 · Received September 26, 2007

    Report

    Report Number
    1525965-2007-00020
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    May 30, 2007
    Report Date
    September 26, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    KPS
    PMA / PMN Number
    K051170
    Removal / Correction Number
    1525965-09/25/07-007C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED TO ADD ADDITIONAL PRODUCT CONFIGURATIONS TO AN MDR PREVIOUSLY FILED ON THE BRILLIANCE EBW WORKSTATION CARDIAC VIEWER (REFERENCE MDR 1525965-2007-00005). ADDITIONAL INVESTIGATION HAS DETERMINED THAT THE ISSUE IMPACTS THE CT SUBSYSTEM OF THE GEMINI GXL PET/CT SYSTEMS AS WELL. NO OCCURRENCES OF THIS EVENT HAVE BEEN REPORTED ON GEMINI GXL SYSTEMS IN THE FIELD. PLEASE REFERENCE THE ABOVE MENTIONED C&R REPORT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE EXTENDED BRILLIANCE WORKSPACE (EBW) HAS AN OPTIONAL SOFTWARE APPLICATION FUNCTION CALLED THE CARDIAC VIEWER. IT IS POSSIBLE FOR AN SET OF IMAGES TO BE EXPANDED OR ZOOMED AND SAVED AS A NEW SET OF IMAGES. WHEN THE SAVED SET OF IMAGES ARE VIEWED USING A FUNCTION CALLED THE CT VIEWER, OR ARE TRANSFERRED TO A PACS (PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM), MEASUREMENTS MADE ON THESE ZOOMED IMAGES ARE INCORRECT. THE MEASUREMENT ERROR IS PROPORTIONAL TO THE ZOOM FACTOR. AN IMAGE WHICH IS ZOOMED BY A FACTOR OF TWO WILL SHOW DISTANCE MEASUREMENTS THAT ARE INCORRECT AND ENLARGED BY A FACTOR OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI GXL 6 SLICE PET/CT SYSTEM GEMINI GXL 6 KPS PHILIPS MEDICAL SYSTEMS, INC. 4535 679 75691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR