BEUDAMED
    FDA Adverse Event Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 14707 · Received July 15, 1994

    Report

    Report Number
    MW1002828
    Date Received
    July 15, 1994
    Report Date
    July 13, 1994
    Manufacturer
    MITSUBISHI INTL CORP.
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    RPTR HAS IDENTIFIED A POTENTIALLY HAZARDOUS SITUATION REGARDING THE USE OF THE LINEAR ACCELERATOR TO TREAT PTS. IT IS POSSIBLE THAT A CALIBRATION CHANGE OF UP TO 25% CAN OCCUR WITHOUT ANY VISUAL INDICATION ON THE MACHINE METERS OR DISPLAYS. ALSO, THERE APPEARS TO BE SAFETY INTERLOCK MECHANISM TO PREVENT THIS FROM HAPPENING. RPTR HAS FOUND THAT THE CALIBRATION SHIFT IS DUE TO A CHANGE IN BEAM ENERGY THAT RESULTS FROM FLUCTUATIONS IN BEAM TUNING PARAMETERS. ALSO, A SIGNIFICANT CHANGE IN BEAM FLATNESS AND SYMMETRY OCCURS, AGAIN WITH NO VISUAL INDICATION ON THE MACHINE METERS OR DISPLAYS AND NO INTERLOCKING. THE BEAM TUNING PARAMETERS CAN FREQUENTLY VARY SIGNIFICANTLY. RPTR HAS OBSERVED UP TO AN 11% CHANGE IN DOSE CALIBRATION FROM ONE DAY TO THE NEXT. THE POSSIBILITY OF CALIBRATION AND FLATNESS/SYMMETRY CHANGES WITHOUT ANY INDICATION OR SAFTEY INTERLOCK MECHANISM TO PREVENT TREATMENT CAN RESULT IN THE MISTREATMENT OF PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR LINEAR ACCELERATOR IYE MITSUBISHI INTL CORP. EXL-14

    Patients

    Seq Age Sex Outcome Treatment
    1 *