BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS

    MDR report key: 1246567 · Received November 14, 2008

    Report

    Report Number
    2443168-2008-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 13, 2008
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RADIOLOGISTS ARE COMPLAINING THAT WHEN SCROLLING THROUGH THE IMAGES OF A SERIES, THE SCROLLING APPEARS CHOPPY, HESITATES, JUMPS AHEAD AND IS NOT SMOOTH. THIS PROBLEM IS SEEN MORE PREDOMINATELY WITH MRI STUDIES THAN CT'S. HOWEVER, THE LARGER THE NUMBER OF IMAGES PER SERIES, THE MORE LIKELY A RADIOLOGIST WILL SEE THIS ISSUE. WHEN A STUDY IS SELECTED, IT POPULATES THE VIEWPORTS. THE RADIOLOGIST WILL SELECT A SERIES TO VIEW AND USING THE MOUSE WHEEL OR BY DEPRESSING THE WHEEL AND DRAGGING, THE IMAGES WILL, FOR INSTANCE, WILL INITIALLY SCROLL WITH HESITATION FROM IMAGE #1 TO IMAGE #5 AND THEN JUMP TO IMAGE #11 AND SO ON. THE APPEARANCE OF THE SERIES WHILE SCROLLING QUICKLY IS NOT A SMOOTH TRANSITION. IT ALSO APPEARS THAT ONCE THE USER HAS INITIALLY SCROLLED THROUGH THE SERIES, THE SCROLLING ISSUE IS NOT AS PRONOUNCED.

    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. SYANPSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1