BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 869603 · Received June 22, 2007

    Report

    Report Number
    2914292-2007-00026
    Event Type
    Malfunction
    Date Received
    June 22, 2007
    Date of Event
    May 14, 2007
    Report Date
    May 25, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASTER LINK HAS BEEN RETURNED FOR INVESTIGATION BY VARIAN MEDICAL SYSTEMS. THERE WAS NO DAMAGE TO THE SECURING PART OF THE MASTER LINK (LINK PLATE AND SPRING CLIP.) IT HAS BEEN DETERMINED THAT THE ROOT CAUSE OF THE GANTRY CHAIN "BREAKING" IS THE MASTER LINK CLIP NOT BEING ENGAGED ALL THE WAY WHEN INSTALLED. TO ALLEVIATE THIS PROBLEM, WE ARE CHANGING OUR ASSEMBLY PROCEDURES TO CLARIFY THE ASSEMBLY AND INSPECTION OF THIS LINK.

    Description of Event or Problem · 1

    DURING PT SET UP, WHILE THE OPERATOR WAS INSIDE THE TREATMENT ROOM, THE OPERATOR NOTICED A "BANG." THE GANTRY MOVEMENT STOPPED AND COULD NOT MOVE ANYMORE. THERE WAS NO COLLISION. THE GANTRY CHAIN WAS FOUND WITH THE MASTER LINK OPEN AND BENT. THE PT ON THE TABLE WAS NOT AFFECTED, THERE WERE NO INJURIES THAT OCCURRED DUE TO THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR