BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 33353 · Received May 8, 1996

    Report

    Report Number
    MW4001336
    Event Type
    Malfunction
    Date Received
    May 8, 1996
    Date of Event
    April 15, 1996
    Report Date
    April 17, 1996
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THERAPIST OBSERVED, VIA IN ROOM MONITOR, A 2MM SHIFT IN COUCH VERTICAL DISTANCE UP WHEN MAKING A LONGITUDINAL ADJUSTMENT. VERTICAL THUMB WHEEL NOT TOUCHED. ELECTRONIC'S TECH: WHEN DROPPED COUCH SKIRT, NOTICED THAT WHENEVER LATERAL, LONGITUDE, OR COUCH ROTATION WERE DRIVEN A SLIGHT MOVEMENT ON VERTICAL DRIVE MOTOR OCCURRED. SET LONGITUDINAL TABLE TOP FULL OUT, SET COUCH VERTICAL ON 110CM ON MONITOR, DROVE COUCH IN AND COUCH RAISED UP, WITHOUT VERTICAL ACTIVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO