BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2190652 · Received July 27, 2011

    Report

    Report Number
    2916710-2011-00097
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF DEVICE MALFUNCTION OF SERIOUS INJURY AS A RESULT OF THIS ISSUE. THE LOOSE INNER STAND BOLT WAS TIGHTENED/TORQUED TO SPECIFICATION BY THE VARIAN FIELD SERVICE ENGINEER. STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS LOOSE STAND BOLT ISSUE, SHOULD IT RECUR, MAY POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A VARIAN FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE CHECKING STAND BOLTS FOR TIGHTNESS DURING AN UNRELATED SERVICE CALL, HE DISCOVERED THAT ONE INNER STAND BOLT WAS LOOSE; THE WASHER UNDER THE BOLT COULD BE TURNED BY HAND. IT IS ASSUMED THAT THIS BOLT WAS FORGOTTEN TO BE TIGHTENED DURING INSTALLATION/RIGGING. THE CLINAC HAS SIX MOUNTING BOLTS THAT HOLD THE STAND TO THE BASE FRAME. FOUR BOLTS ARE ACCESSIBLE FROM THE OUTSIDE AND WERE TIGHTENED ON THIS MACHINE. THERE ARE TWO MORE BOLTS - ONLY ACCESSIBLE FROM THE INSIDE - ONE WAS LOOSE. ALL SIX BOLTS SHOULD HAVE BEEN TIGHTENED WITH 1017 NM DURING RIGGING. A SPECIAL TOOL IS NEEDED TO REACH THESE INNER STAND BOLTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1