BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 78877 · Received March 28, 1997

    Report

    Report Number
    MW4001834
    Event Type
    Malfunction
    Date Received
    March 28, 1997
    Date of Event
    October 17, 1996
    Report Date
    October 30, 1996
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF PT, GANTRY MOVED 22 DEGREES AND DOSE RATE METER INDICATED BEAM WAS TURNING ON AND OFF, SHOWING HIGHER DOSE RATE THAN NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN ASSOC, INC. 1800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR