BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1674377 · Received April 29, 2010

    Report

    Report Number
    2916710-2010-00046
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM EXISTS WHEN VARIOUS STEPS IN THE CBCT ACQUISITION AND MATCH PROCESS OCCUR - SUCH AS LOADING THE REFERENCE CT DATASET, LOADING THE CBCT DATASET AND SAVING THE CBCT DATASET - COMPUTER MEMORY IS CONSUMED. NOT ALL OF THIS COMPUTER MEMORY IS FREED UP FOR REUSE WHEN THE PT IS CLOSED. THEREFORE, AS MORE PTS ARE SCANNED USING CBCT, THERE MAY BE INSUFFICIENT MEMORY FOR OBI APPLICATION TO CONTINUE TO OPERATE. VARIAN HAS PROVIDED A CUSTOMER TECHNICAL BULLETIN TO INFORM USERS OF A SOLUTION WHEN THIS PROBLEM OCCURS. IF MEMORY LOG SUGGESTS THAT ALL OF THE FREE MEMORY MAY POTENTIALLY BE CONSUMED, THE SOLUTION IS TO CLOSE THE OBI APPLICATION AFTER EVERY 10 CBCT SCANS. RESTARTING THE OBI APPLICATION WILL FREE UP THE AVAILABLE MEMORY AND WILL ALLOW THE OBI TO OPERATE NORMALLY. ALTHOUGH THERE WAS NO SERIOUS INJURY REPORTED IN THIS CASE, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD RESULT IN UNINTENDED RADIATION TO THE WRONG ANATOMICAL SITE. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONCE THEY IMAGED, THEY WENT TO THE ANALYZE WORKSPACE AND THERE WERE SHIFTS IN THE DASHBOARD BEFORE THEY EVEN TRIED TO MATCH, AND WHEN THEY DID TRY AND MATCH THE MATCH, THE SHIFTS DIDN'T GO AWAY. THEY TRIED THIS 3 SEPARATE TIMES AND HAD THE SAME RESULTS EACH TIME. THE REPORT DID NOT PROVIDE PT INFO OR INFO REGARDING SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD IMAGER (OBI) ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1