BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN

    MDR report key: 126768 · Received October 16, 1997

    Report

    Report Number
    MW1012291
    Event Type
    Malfunction
    Date Received
    October 16, 1997
    Date of Event
    September 25, 1997
    Report Date
    October 2, 1997
    Manufacturer
    VARIAN ASSOC. INC
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    WHILE THE ACCELERATOR GANTRY WAS BEING ROTATED, THE CENTER COVER BROKE LOOSE NEARLY HITTING THE PT'S HEAD. THE COVER HAD BEEN ATTACHED WITH ONLY TWO SCREWS, BUT SEVERAL OTHER SCREW HOLES WERE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN LINEAR ACCELERATOR IYE VARIAN ASSOC. INC CLINAC 2100C *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other