BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1689232 · Received May 5, 2010

    Report

    Report Number
    2916710-2009-00086
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    January 9, 2009
    Report Date
    January 9, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER REVIEW OF THE INITIAL CUSTOMER REPORT, IT WAS DISCOVERED THAT 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, A 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 WAY 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. AN INTERNAL REVIEW FOLLOWING A SUBSEQUENT REPORT OF THIS ISSUE HAS LED TO THE DECISION TO REPORT THIS OLDER REPORT. NO ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY CBCT SCANNED PT A, MATCHED, APPLIED SHIFTS, TREATED AS USUAL AND CLOSED PT A. THEY MOVED ON TO PT B (ID (B)(6)), SCANNED, MATCHED MAKING ONLY A VERY SMALL VERT MOVE, APPLIES SHIFT AND NOTICED THE SHIFT WAS THE SAME TARGET POSITIONS AS PT A. THIS IS CONFIRMED BY COMPARING THE TARGET COUCH POSITIONS FROM PRINTED SCREEN CAPTURES. THEY RE-SCANNED, RE-MATCHED AND GOT THE SAME RESULTS. HOWEVER, AFTER REBOOTING OBI AND 4DITC, THE CORRECT SHIFTS WERE APPLIED. NO PT WAS MISTREATED, AND NO OTHER PT INFO WAS REPORTED.

    Additional Manufacturer Narrative · 2

    DURING FURTHER REVIEW OF THE INITIAL CUSTOMER REPORT, IT WAS DISCOVERED THAT 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, A 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 WAY 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 A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD RESULT IN UNINTENDED RADIATION TO THE WRONG ANATOMICAL SITE. AN INTERNAL REVIEW FOLLOWING A SUBSEQUENT REPORT OF THIS ISSUE HAS LED TO THE DECISION TO REPORT THIS OLDER REPORT. NO ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 2

    THE CUSTOMER REPORTED THAT THEY CBCT SCANNED PT A (ID (B)(6)), MATCHED, APPLIED SHIFTS, TREATED AS USUAL AND CLOSED PT A. THEY MOVED ON TO PT B, SCANNED, MATCHED MAKING ONLY A VERY SMALL VERT MOVE, APPLIES SHIFT AND NOTICED THE SHIFT WAS THE SAME TARGET POSITIONS AS PT A. THIS IS CONFIRMED BY COMPARING THE TARGET COUCH POSITIONS FROM PRINTED SCREEN CAPTURES. THEY RE-SCANNED, RE-MATCHED AND GOT THE SAME RESULTS. HOWEVER, AFTER REBOOTING OBI AND 4DITC, THE CORRECT SHIFTS WERE APPLIED. NO PT WAS MISTREATED, AND NO OTHER PT INFO WAS REPORTED.

    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
    2