BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2141334 · Received June 1, 2011

    Report

    Report Number
    2916710-2011-00059
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K033343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF DEVICE MALFUNCTION OR SERIOUS INJURY AS A RESULT OF THIS ISSUE. 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. 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 THE SYSTEM'S STAND BOLTS FOR TIGHTNESS DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION (PMI), THAT BOTH INNER STAND BOLTS WHERE FOUND TO BE LOOSE.

    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