BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS

    MDR report key: 679147 · Received February 17, 2006

    Report

    Report Number
    2443168-2006-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2006
    Date of Event
    January 22, 2006
    Report Date
    February 17, 2006
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN VIEWING CT SCANNED IMAGES, IF THE SHARPEN PRESET (WINDOW / LEVEL) IS ADDED, THE ORIENTATION OF THE IMAGE ON THE HORIZONTAL AXIS CHANGES, BUT THE MARKERS ARE NOT CHANGED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACS SYSTEM. IMAGE PROCESSING, RADIOLOGICAL LLZ FUJIFILM MEDICAL SYSTEM U.S.A., INC. SYNAPSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other