BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN MEDICAL SYSTEMS LINEAR ACCELERATOR

    MDR report key: 2834825 · Received October 15, 2012

    Report

    Report Number
    MW5027623
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    VARIAN MED SYSTEMS, INC
    Product Code
    IYE
    Product Problem
    Yes
    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 VARIAN 2100EX ACCELERATORS TO TREAT PTS WITH RADIATION THERAPY. THESE DEVICES WERE UPGRADED IN OCTOBER OF 2010. PRIOR TO THE UPGRADES WE HAD THE ABILITY TO BAR CODE INDIVIDUAL RADIATION BEAM MODIFIERS (BLOCKS, COMPENSATORS, ETC.) WHICH WERE SPECIFIC TO A GIVEN PT AND GIVEN RADIATION FIELD. IF A BEAM MODIFIER WAS REQUIRED BUT NOT PRESENT THE 2100EX WOULD "INTERLOCK" AND PREVENT THE APPLICATION OF THE RADIATION FOR THAT FIELD. THIS PROCEDURE WAS A VERY IMPORTANT PART OF OUR QUALITY ASSURANCE PROGRAM AS IT PREVENTED THE INCORRECT APPLICATION OF RADIATION TO OUR PTS. AFTER THE UPGRADE OF THE 2100EX VARIAN NO LONGER SUPPORTED THIS FEATURE. WE WERE NOT INFORMED THAT THIS FEATURE WOULD BE OMITTED POST UPGRADE. THIS COMMISSION IS CONSIDERED NEGLIGENCE ON THE PART OF THE MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention