BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUALPACS

    MDR report key: 538756 · Received August 12, 2004

    Report

    Report Number
    2135350-2004-00003
    Event Type
    Other
    Date Received
    August 12, 2004
    Date of Event
    July 12, 2004
    Report Date
    August 10, 2004
    Manufacturer
    EMAGEON UV, INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE VERIFICATION PHASE OF PRODUCT DEVELOPMENT AT THE MANUFACTURER, A REVIEW OF SOURCE CODE UNCOVERED THE FACT THAT ALL MULTI-FRAME IMAGES WITHOUT PIXEL SPACING DATA ARE BEING DISPLAYED IN THE VIEWER AS BEING CALIBRATED EVEN THOUGH THEY ARE NOT. THIS CAN LEAD TO POTENTIALLY INACCURATE MEASUREMENTS ON AN IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUALPACS MEDICAL IMAGE MANAGEMENT DEVICE LLZ EMAGEON UV, INC. 2.3X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other