BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1821785 · Received August 26, 2010

    Report

    Report Number
    2916710-2010-00101
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPAIRED THE MANIFOLD AND VERIFIED CLINAC OPERATION. NEW PARTS HAVE BEEN ORDERED FOR FUTURE REPLACEMENT. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INCOMING WATER LEAKING AT WATER MANIFOLD AT THE BYPASS VALUE FOR THE 2ND TIME IN 6 WEEKS. APPEARS TO BE AN ISSUE WITH THE BY PASS VALUES ON THE MANIFOLDS. THE CUSTOMER CAME IN TO DO MORNING CHECKOUT AND WATER WAS ALL ON THE FLOOR. LEAKS IN THE STAND AT THE INCOMING WATER MANIFOLD AT THE BYPASS VALUE. THERE WAS NO REPORT OF SERIOUS INJURY TO THE PT OR OPERATOR. NO PT DATA REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1