BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 883424 · Received July 19, 2007

    Report

    Report Number
    2914292-2007-00027
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 19, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHAIN WAS REPLACED AND THE MASTER LINK WAS 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, VARIAN IS CHANGING OUR ASSEMBLY PROCEDURE TO CLARIFY THE ASSEMBLY AND INSPECTION OF THIS LINK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSTALLATION, THE GANTRY CHAIN SLACKED AFTER 2 DAYS OF USE. THE BREAK OF THE GANTRY CHAIN OCCURRED. A NEW PART WAS ORDERED FOR REPLACEMENT, HOWEVER IN THE MEANTIME THE ORIGINAL PART REMAINS ON THE EQUIPMENT AND NEW STB CHECKS HAVE BEEN CORRECTLY PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR