BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2192554 · Received July 1, 2011

    Report

    Report Number
    2916710-2011-00078
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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 OR SERIOUS INJURY AS A RESULT OF THIS ISSUE. THIS IS A KNOWN ISSUE WHICH HAS PREVIOUSLY BEEN REPORTED AND CURRENTLY UNDER INVESTIGATION. THE TWO LOOSE INNER STAND BOLTS WERE TIGHTENED/TORQUED TO SPECIFICATION BY THE VARIAN FIELD SERVICE ENGINEER. THE SYSTEM WAS VERIFIED AND FOUND TO BE FUNCTIONING TO SPECIFICATION. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS LOOSE STAND BOLT ISSUE, SHOULD IT RECUR, MAY POTENTIALLY RESULT IN SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A VARIAN FIELD SERVICE ENGINEER (FSR) CHECKED THE STAND BOLTS FOR TIGHTNESS DURING A SERVICE CALL SINCE OTHER INCIDENTS OF LOOSE STAND BOLTS HAVE BEEN REPORTED. HE DISCOVERED THAT BOTH INNER STAND BOLTS WERE LOOSE. WASHERS UNDER THE BOLT CAN BE TURNED BY HAND. SO WE ASSUME THAT THEY HAVE FORGOTTEN TO GET TIGHTENED DURING INSTALLATION. THE CLINIC 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 - THAT WERE LOOSE. ALL SIX BOLTS SHOULD HAVE BEEN TIGHTENED WITH 1017 NM DURING RIGGING. A SPECIAL TOOL IS NEEDED TO REACH INNER STAND BOLTS. (SECOND DEVICE AT SAME FACILITY WITH THIS ISSUE).

    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