BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUAL PACS

    MDR report key: 473867 · Received July 22, 2003

    Report

    Report Number
    2135350-2003-00003
    Event Type
    Other
    Date Received
    July 22, 2003
    Date of Event
    June 27, 2003
    Report Date
    July 21, 2003
    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

    ON MR BRAINS AND SPINES, THE LEFT/RIGHT VIEWPORT LABEL FOR DICOM TAG (0020,1041) SLICELOCATION SEEMS TO BE WRONG. WHEN SCROLLING TO THE RIGHT SIDE OF THE BRAIN THE DISPLAY SAYS "L" ON THE LINKED SAGITAL VIEW - AND VICE VERSA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other