BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIAN MEDICAL SYSTEMS LINEAR ACELLERATOR

    MDR report key: 2794669 · Received October 11, 2012

    Report

    Report Number
    MW5027250
    Event Type
    Other
    Date Received
    October 11, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS INSTITUTION HAS BEEN USING A VARIAN 2100 EX ACCELERATOR TO TREAT PTS WITH RADIATION THERAPY. THESE DEVICES WERE UPGRADED IN OCTOBER OF 2010. PRIOR TO THE UPGRADE WE HAD THE ABILITY TO BAR CODE INDIVIDUAL BEAM MODIFIERS (BLOCKS, COMPENSATORS, ETC) WHICH WERE SPECIFIC TO A GIVEN PT, AND GIVEN RADIATION BEAM. IF A BEAM MODIFIER WAS REQUIRED FOR A GIVEN PT AND GIVEN FIELD, IF THIS MODIFIER WAS NOT PRESENT PRIOR TO THE APPLICATION OF THE BEAM, THE 2100EX WOULD "INTERLOCK" AND PREVENT US FROM TREATING THIS FIELD UNTIL THE BEAM MODIFIER WAS IN PLACE. THIS PROCEDURE WAS A VERY IMPORTANT FEATURE IN OUR QUALITY ASSURANCE PROGRAM. IT PREVENTED THE APPLICATION OF THE BEAM IF IT WAS NOT CORRECT. AFTER THE UPGRADE OF THE 2100 EX VARIAN NO LONGER SUPPLIED THIS FEATURE OF THE UPGRADED ACCELERATOR. THIS OMISSION OF THIS FEATURE AFTER THE UPGRADE IS CONSIDERED NEGLIGENCT ON THE PART OF THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN MEDICAL SYSTEMS LINEAR ACELLERATOR LINEAR ACELLERATOR IYE VARIAN MEDICAL SYSTEMS, INC. 2100 EX NA

    Patients

    Seq Age Sex Outcome Treatment
    1