BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE EBW WORKSTATION CARDIAC VIEWER

    MDR report key: 874065 · Received June 29, 2007

    Report

    Report Number
    1525965-2007-00005
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    May 30, 2007
    Report Date
    June 29, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K982060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 SAVE 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. THEY 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 OR TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE EBW WORKSTATION CARDIAC VIEWER VIEWING WORKSTATION FOR CT IMAGES JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR