BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 959020 · Received December 4, 2007

    Report

    Report Number
    2914292-2007-00048
    Event Type
    Malfunction
    Date Received
    December 4, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 14, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - ACTUAL DEVICE IN INCIDENT WAS EVALUATED BY A VARIAN ENGINEER. VISUAL EXAMINATION WAS MADE. RESULTS: INCORRECT TECHNIQUE/PROCEDURE WAS USED WHEN INSTALLING THE MASTER LINK ON THE GANTRY DRIVE CHAIN. CONCLUSION: DEVICE MAINTENANCE CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN REPAIRED AND RETURNED. THE GANTRY CHAIN MASTER LINK AND THE GANTRY CHAIN HAVE 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, VARIAN MEDICAL SYSTEMS IS CHANGING THE ASSEMBLY PROCEDURES TO CLARIFY THE PROPER ASSEMBLY AND INSPECTION OF THIS LINK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THAT THEY WERE USING THE AUTO-GO-TO FUNCTION TO SET UP CLINAC POSITIONS FOR TREATMENT, WHEN A LOUD SOUND WAS HEARD. THE CUSTOMER NOTICED THAT ALL MOTIONS WERE CONTINUING EXCEPT FOR GANTRY MOVEMENT. THE CUSTOMER THEN CALLED THE VARIAN SERVICE REPRESENTATIVE. UPON INSPECTING THE CLINAC, THE SERVICE REPRESENTATIVE DISCOVERED THAT THE GANTRY CHAIN HAD SEPARATED AT THE MASTER LINK WITH THE GANTRY AT APPROXIMATELY 270 DEGREES. THERE WAS A PT ON THE TREATMENT TABLE, BUT THERE WERE NO INJURIES AS A RESULT OF THIS EVENT. THERE WAS NO TREAT OF A COLLISION, AS THE GANTRY DID NOT MOVE AFTER THE CHAIN BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS CL-IX TRILOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 YR