BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUALPACS

    MDR report key: 508665 · Received January 9, 2004

    Report

    Report Number
    2135350-2004-00001
    Event Type
    Other
    Date Received
    January 9, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 8, 2004
    Manufacturer
    EMAGEON UV, INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE DEMONSTRATION AT A CUSTOMER SITE, IT WAS FOUND THAT DATA SETS THAT ARE TRANSFERRED FROM THE DICOM SERVER AS UN-CALIBRATED WITH DIFFERENT FIELDS OF VIEW FROM SLICE TO SLICE, CANNOT BE CALIBRATED CORRECTLY. THE PROBLEM IS EXHIBITED IN THE FOLLOWING WAY: IF AN IMAGE IS MANUALLY CALIBRATED USING ULTRAVISUAL TOOLS, THE OTHER SLICES (THAT HAVE DIFFERENT FIELDS OF VIEW) WILL INHERIT THE CALIBRATION OF THE ORIGINAL IMAGE. THE RESULT IS THAT IMAGES OTHER THAN THE INITIAL IMAGE CALIBRATED, WILL HAVE AN INCORRECT CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUALPACS MEDICAL IMAGE MANAGEMENT DEVICE LLZ EMAGEON UV, INC. 2.2.1M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other