BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREA

    MDR report key: 148829 · Received February 13, 1998

    Report

    Report Number
    1933477-1998-00001
    Event Type
    Malfunction
    Date Received
    February 13, 1998
    Date of Event
    January 21, 1998
    Report Date
    February 13, 1998
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOMS OF THE PROBLEM REPORTED IN THE INITIAL REPORT OF 2/13/98 HAVE BEEN INVESTIGATED AND ARE NOW WELL UNDERSTOOD, AND THE ROOT CAUSE HAS BEEN ISOLATED AND CORRECTED. A SAFETY ALERT NOTICE DESCRIBING THE SIMPLE PRECAUTIONS REQUIRED TO AVOID THE ERROR WILL BE SENT IMMEDIATELY TO ALL CUSTOMERS. A MANDATORY MAINTENANCE UPGRADE OF THE SOFTWARE WILL BE SUPPLIED TO ALL CUSTOMERS BY THE END OF FEBRUARY.

    Description of Event or Problem · 1

    THE PRODUCT, A RADIOLOGICAL VIEWING WORKSTATION INTENDED FOR USE AS A DIAGNOSTIC AID, PROVIDES 2D AND 3D VIEWING OF CT OR MR IMAGES. AFTER DIAGNOSIS, IN ORDER TO COMMUNICATE THE RESULTS OF DIAGNOSIS, THE HEALTHCARE PROFESSIONAL MAY PRINT A REPORT OF RADIOLOGICAL IMAGES. TO DATE, IT HAS BEEN REPORTED FROM ONE FACILITY THAT IN APPROX FOUR INSTANCES, THE REPORT HEADER SHOWED A PT NAME DIFFERENT FROM THE ACTUAL PT IMAGE ON THE REPORT. NO INCORRECT DIAGNOSES NOR ADVERSE PT OUTCOMES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITREA 3D RADIOLOGY VIEWER SOFTWARE LLZ VITAL IMAGES, INC. 1.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN