BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMULIX RADIOTHERAPY SIMULATOR WITH CT EXTENSION

    MDR report key: 127800 · Received September 25, 1997

    Report

    Report Number
    1121753-1997-00029
    Event Type
    Other
    Date Received
    September 25, 1997
    Date of Event
    April 30, 1997
    Report Date
    September 25, 1997
    Manufacturer
    NUCLETRON BV
    Product Code
    KPQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE SCANS WERE PERFORMED WITH SIMULATOR/CT EXTENSION. THE FOURTH SCAN WAS ABORTED AT 120 DEGREES WITH MESSAGE THAT TOUCHBAR WAS ACTIVATED. TECHNICIAN SHOOK AFTERSLIT WHICH FELL DOWN AND GRAZED PTS THORAX. NO INJURY OCCURRED. TWO SCREWS WERE FOUND MISSING, ONE RUSTED SCREW WAS IN PLACE. SCREWS WERE REPLACED AND LOCKTITE'D IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMULIX RADIOTHERAPY SIMULATOR WITH CT EXTENSION RADIOTHERAPY SIMULATOR SYSTEM KPQ NUCLETRON BV 12T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other