BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1063669 · Received June 20, 2008

    Report

    Report Number
    2954704-2008-00004
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 18, 2008
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FROM RESERVE SAMPLE EVALUATED. THE MPR FEATURE IS ONLY IN 3.5.X VERSIONS OF ISITE AND IS NOT UTILIZED BY THE MAJORITY OF USER FACILITIES. DUE TO THIS ISSUE AND PREVIOUSLY IDENTIFIED DEFECTS, A PRODUCT NOTIFICATION WILL BE SENT OUT TO ALL 3.5 CUSTOMERS AND THE FEATURE WILL BE DISABLED FROM ALL ISITE 3.5.X INSTALLS.

    Description of Event or Problem · 1

    THE SCOUT LINES AND LOCALIZER CROSSHAIRS WHEN ENABLED ON MULTI PLANAR RECONSTRUCTION (MPR) IMAGES, CREATED BY ISITE UNDER THE FOLLOWING CONDITIONS, WILL DISPLAY AT THE WRONG TRIANGULATION POSITION REPRESENTING THE IMAGE LOCATIONS OF THE OTHER ORTHOGONAL PLANES. THE IMAGE DATA IS ACQUIRED WHEN GANTRY IS TILTED. ISITE SYSTEM PREFERENCE UNDER "MAXIMUM VARIANCE FOR LINKING" IS CONFIGURED WITH MORE THAN 2 DEGREES FROM THE ANGLE OF THE GANTRY TILT DURING ACQUISITION OF THE ORIGINAL DATASET. MPR IMAGES ARE NOT AFFECTED BY THIS ERROR - ONLY THE SCOUT LINE AND LOCALIZER CROSSHAIR PLACEMENT ON THE MPR IMAGES ARE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS PICTURE ARCHIVING AND COMMUNICATION SYS LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other