BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MHI-TM2000 LINEAR ACCELERATOR SYSTEM/ VERO

    MDR report key: 3979596 · Received July 17, 2014

    Report

    Report Number
    3006942329-2014-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 28, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MITSUBISHI HEAVY INDUSTRIES LTD.
    Product Code
    IYE
    PMA / PMN Number
    K122450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TOTAL NINETEEN DEVICES (ALL VERSION 3.0.0 AND AFTER) HAVE THIS SOFTWARE PROBLEM, INCLUDING THREE IN THE U.S. ACTIONS PLANNED TO BE TAKEN BY MFR. MHI HAS REACHED ALL POSSIBLY AFFECTED CUSTOMERS WITH A "PRELIMINARY CUSTOMER INFO LETTER" ALERTING THEM TO THIS ISSUE. MHI IS NOTIFYING ALL POSSIBLY AFFECTED CUSTOMERS WITH A FIELD SAFETY NOTICE TOGETHER WITH (B)(4). MHI WILL ISSUE "REPORT OF CORRECTION AND REMOVAL" TO FDA. BRAINLAB AG AND MHI WILL FURTHER INVESTIGATE WHETHER ANY OTHER CUSTOMERS USING AN AFFECTED DEVICE HAVE BEEN EXPERIENCED SAME PROBLEM AS WELL AS WHETHER ANY OTHER CUSTOMERS HAVE PERFORMED INCORRECT TREATMENT DUE TO THE PROBLEM. FOR THIS PURPOSE, MHI IS CREATING A SOFTWARE TOOL TO AUTOMATICALLY CHECK INCONSISTENCIES OF PT TREATMENT FRACTIONS IN R&V SYSTEM DATABASE. AFTER THE TOOL BECOMES AVAILABLE, BRAINLAB AG, WHICH IS SALES AND SERVICE REP OF THE VEROTM / MHI-TM2000 LINEAR ACCELERATOR SYSTEM, WILL CHECK R&V DATABASE OF EACH HOSPITAL WITH THE ASSISTANCE OF EACH HOSPITAL REP. THE RESULTS OF THE CHECK WILL BE RECORDED. IF AN INCONSISTENCY PROBLEM IS FOUND, MHI WILL FURTHER INVESTIGATE IT IN COLLABORATION WITH THE CUSTOMER TO DETERMINE WHETHER A POTENTIAL MISTREATMENT EXISTS. MHI HAS OPENED A CAPA AND IS DEVELOPING A CORRECTION FOR THIS ISSUE. TENTATIVELY PLANNED AVAILABILITY DATE: END OF 08/2014. ESTIMATED SOFTWARE UPDATE COMPLETION DATE: END OF 12/2014. THE CORRECTION WILL BE FREE OF CHARGE AND OUR CUSTOMER SERVICE REP WILL CONTACT AFFECTED CUSTOMERS TO SCHEDULE ITS INSTALLATION AS SOON AS CORRECTION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS THE SECOND MEDWATCH REPORT MHI SUBMITS TO FDA ABOUT AN EVENT CAUSED BY THE SAME SOFTWARE ANOMALY OF MHI-TM2000 LINEAR ACCELERATOR SYSTEM WE HAD REPORTED ON JULY 11, 2014. THIS EVENT OCCURRED ON (B)(6) 2014. THERE WAS NO ADVERSE EVENT, BUT WERE THE MALFUNCTION TO OCCUR AGAIN. THERE WOULD BE A RISK OF DEATH OR SERIOUS INJURY. THE RECORD AND VERIFY SYSTEM ("A&V SYSTEM") OF MHI-TM2000 LINEAR ACCELERATOR SYSTEM HAS A CALENDAR USED FOR TREATMENT SCHEDULING. DUE TO A CERTAIN SOFTWARE BUG, IF A USER CHANGES THE CALENDAR SETTING FROM "WORKDAY" TO "HOLIDAY" OR VICE VERSA, THAT WOULD ERRONEOUSLY CHANGE THE STATUS OF FRACTIONS WHICH ARE COMPLETED AND NO BECOME "TREATED (COMPLETED)" STATUS ON THE EXACT DAY WHEN SUCH CHANGE IS MADE, TO "UNTREATED" STATUS. ONE OF OUR CUSTOMERS IN (B)(6) (THE "CUSTOMER"), HAD FOUND THIS PROBLEM AND IT WAS REPORTED TO THE LOCAL TECHNICAL ENGINEER IN MAY 2014. ACCORDING TO THE EXPLANATION PROVIDED BY THE CUSTOMER, WE UNDERSTAND THAT FOLLOWING HAPPENED: THE CUSTOMER PROVIDED TWENTY RADIOTHERAPIES ON (B)(6) 2014. FOUR OF THEM WERE THE LAST FRACTION OF EACH TREATMENT PLAN AND THE USER CONFIRMED THAT THE STATUS OF THE FOUR FRACTIONS TURNED TO "TREATED (COMPLETED)" AFTER EACH TREATMENT. LATER ON THE SAME DAY, THE USER CHANGED CALENDAR SETTING OF A FUTURE DATE ((B)(6)) IN R&V SYSTEM, FROM "WORKDAY" TO "HOLIDAY", BY MISTAKE AND SET THEM BACK TO THE PREVIOUS, CORRECT SETTING. THEN THE USER FOUND THAT THE FOUR FRACTIONS, WHICH TREATMENT HAD BEEN COMPLETED EARLIER ON THE DAY. THE USER DELETED THEM MANUALLY. THE ABOVE CASE WAS ALSO REPORTED TO MHI BY OUR LOCAL SALES AND SERVICE REP, BRAINLAB ON (B)(4) 2014. IN LIGHT OF OUR ANALYSIS OF A SIMILAR EVENT REPORTED TO US ON JUNE 26, 2014, WHICH WE HAVE REPORTED TO FDA ON JULY 11, 2014, WE ARE REPORTING THIS EVENT NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420524 MHI-TM2000 LINEAR ACCELERATOR SYSTEM/ VERO MEDICAL LINEAR ACELERATOR IYE MITSUBISHI HEAVY INDUSTRIES LTD. VER.3.2 #2

    Patients

    Seq Age Sex Outcome Treatment
    1