BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 513782 · Received January 16, 2004

    Report

    Report Number
    2914292-2004-00001
    Event Type
    Other
    Date Received
    January 16, 2004
    Date of Event
    November 17, 2003
    Report Date
    January 15, 2004
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING STATMENT IS THE INCIDENT DESCRIPTION THAT WAS SUBMITTED BY THE HOSP: "MACHINE FIBERGLASS COVER FELL ON PATIENT. SCREW ON THE LATCH WERE NOT IN PLACE." THE PATIENT WAS NOT INJURED. VARIAN DOES NOT BELIEVE THAT THERE HAS BEEN ANY MALFUNCTION OF THE DEVICE, NOR IF THIS INCIDENT WERE TO RECUR, WOULD IT BE LIKELY TO CAUSE ANY SERIOUS INJURY OR DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other