BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 365943 · Received December 7, 2001

    Report

    Report Number
    8022247-2001-00014
    Event Type
    Malfunction
    Date Received
    December 7, 2001
    Date of Event
    November 5, 2001
    Report Date
    December 6, 2001
    Manufacturer
    MDS NORDION
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONGOING FACTORY TESTING OF ELITE SOFTWARE FOUND THE FOLLOWING ISSUES WHICH COULD BE ENCOUNTERED BY A USER. 1. POSSIBLE UNWANTED GANTRY MOTION WHEN USING THE OPTIONAL "REMOTE GANTRY FUNCTION" FEATURE TO MOVE THE GANTRY REMOTELY. 2. POSSIBILITY OF GETTING A QNX OPERATING SYSTEM COMMAND PROMPT WHILE THE ELITE SOFTWARE IS RUNNING. 3. INCONSISTENT GRAPHICAL USER INTERFACE (GUI) BEHAVIOUR BY PRESSING AND HOLDING A SCREEN BUTTON FOR SEVERAL SECONDS EITHER BY PRESSING AND HOLDING THE LEFT MOUSE BUTTON OR BY PRESSING AND HOLDING THE "ENTER" KEY ON THE KEYBOARD. NOTE: THERE HAVE BEEN NO REPORTS OR OCCURRENCES OF THE ISSUES REPORTED BY USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55332 THERATRON COBALT THERAPY DEVICE IWB MDS NORDION ELITE 80 & ELITE 100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other