BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN MEDICAL SYSTEMS

    MDR report key: 916163 · Received September 17, 2007

    Report

    Report Number
    MW5003798
    Event Type
    Malfunction
    Date Received
    September 17, 2007
    Date of Event
    January 24, 2007
    Report Date
    September 17, 2007
    Manufacturer
    VARIAN
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007: DURING TREATMENT ON LINEAR ACCELERATOR EQUIPMENT- PT HIT ON FOREHEAD BY GANTRY AS TABLE WAS NOT ROTATED BACK TO "0" PRIOR TO MOVING GANTRY. NO PERMANENT INJURY TO PT. ON APPROX FOUR AND A HALF MONTHS LATER: NOTIFIED OF 2 ADDITIONAL GANTRY INCIDENTS. THOUGHT TO BE CAUSED BY EQUIPMENT MALFUNCTION. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN MEDICAL SYSTEMS LINEAR ACCELERATOR - GANTRY TABLE IYE VARIAN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other