BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC 600

    MDR report key: 215975 · Received March 23, 1999

    Report

    Report Number
    MW1015971
    Event Type
    Malfunction
    Date Received
    March 23, 1999
    Date of Event
    March 22, 1999
    Report Date
    March 22, 1999
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNCONTROLLED MOTION OF GANTRY OF 40 DEGREES (50-90) OCCURRED AFTER FOUR 1/4" BOLTS SHEARED. AT LEAST ONE OF THE FOUR BOLTS HAD SHEARED ON 3/19/99, BUT HAD NOT BEEN IDENTIFIED OTHER THAN AN OBSERVATION OF A LOUD POPPING NOISE. THE MOUNTING BRACKET FOR THE HARMONIC DRIVE SNAPPED AT THE TIME OF THIS INCIDENT AS WELL. THE DRIVE CHAIN FOR THE GANTRY MOTION BECAME DISENGAGED, AND THE GANTRY ROTATED UNTIL THE DRIVE CHAIN JAMMED AND HALTED ITS MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 600 LINEAR ACCELERATOR IYE VARIAN ASSOC., INC. CLINAC 600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other