BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMULATOR HP

    MDR report key: 469446 · Received June 27, 2003

    Report

    Report Number
    1121753-2003-00002
    Event Type
    Other
    Date Received
    June 27, 2003
    Date of Event
    April 30, 2003
    Report Date
    June 25, 2003
    Manufacturer
    NUCLETRON BV
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DURING ACQUISITION OF SIMULATOR CT IMAGES THE GANTRY STOPPED. UNDER GRAVITY THE FILM CASSETTE HAD SLIPPED AND RELEASED THE LOCKING HANDLES OF THE CT AFTER-SPLIT. SINCE THE AFTER-SLIT WAS NOT IN THE CORRECT POSITION, THE GANTRY WOULD NOT ROTATE. TO CORRECT THE PROBLEM, THE TECHNOLOGIST TRIED TO ADJUST THE FILM CASSETTE IN POSITION. IN DOING SO, THE CT AFTER-SLIT FELL AND THE EDGE OF THE AFTER-SLIT HIT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMULATOR HP RADIATION THERAPY SIMULATOR WITH CT EXTENSION KPQ NUCLETRON BV HP MARK 1/CTX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other