BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINEAR ACCELERATION

    MDR report key: 19703 · Received February 13, 1995

    Report

    Report Number
    19703
    Event Type
    Other
    Date Received
    February 13, 1995
    Date of Event
    July 19, 1994
    Report Date
    October 7, 1994
    Manufacturer
    VARIAN ONCOLOGY SYSTEMS
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SETTING UP RADIATION THERAPY TO THE BRAIN AS ORDERED BY THE PHYSICIAN, THE Y-AXIS OF THE FIELD SIZE WAS INADVERTENTLY REVERSED PRIOR TO TREATMENT ON THE RIGHT SIDE ONLY. THE BRAIN WAS NOT TREATED TO THE CORRECT DOSE ON THE RIGHT SIDE, AS THE NECK WAS TREATED INSTEAD. THE LEFT SIDE OF THE BRAIN WAS TREATED CORRECTLY.THIS WAS REPROT ALSO TO THE DEPARTMENT OF HRS OFFICE OF RADIATION CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATION RADIATION THERAPY LHN VARIAN ONCOLOGY SYSTEMS VARIAN 2500C

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other