BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MHI-TM2000 LINEAR ACCELERATOR SYSTEM/VERO(TM)

    MDR report key: 4022760 · Received July 10, 2014

    Report

    Report Number
    3006942329-2014-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MITSUBISHI HEAVY INDUSTRIES LTD.
    Product Code
    IYE
    PMA / PMN Number
    K122450
    Removal / Correction Number
    "REPORT OF CORRECTION AN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED BY THE CUSTOMER AT THIS MOMENT, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, BUT WE FILE THIS REPORT BECAUSE THE DEVICE MALFUNCTIONED. WE ARE CURRENTLY TRYING TO COLLECT FURTHER INFO REGARDING THE INCIDENT. TOTAL NINETEEN DEVICES (ALL VERSION 3.0.0 AND AFTER) HAVE THIS SOFTWARE PROBLEM, INCLUDING THREE IN THE U.S. PLEASE SEE ATTACHED AFFECTED CUSTOMER LIST IN U.S. ON PAGE 5. <ACTIONS PLANNED TO BE TAKEN BY MANUFACTURER> MFR (MHI) INFORMED THE CUSTOMER ABOUT THIS INCIDENT TOGETHER WITH (B)(4) WHICH IS THE SALES AND SERVICE REP OF MHI-TM2000. MHI HAS REACHED ALL POSSIBLY AFFECTED CUSTOMERS WITH A "PRELIMINARY CUSTOMER INFO LETTER" ALERTING THEM TO THIS ISSUE. FURTHER, MHI IS NOTIFYING ALL POSSIBLY AFFECTED CUSTOMERS WITH A FIELD SAFETY NOTICE TOGETHER WITH BRAINLAB AG AS SOON AS POSSIBLE. THE FSN INCLUDES DESCRIPTION OF THE PROBLEM AND INTERIM ACTIONS TO BE TAKEN BY CUSTOMERS BEFORE THE PROBLEM IS CORRECTED. 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. MHI HAS OPENED A CAPA AND IS DEVELOPING A CORRECTION FOR THIS ISSUE. TENTATIVELY PLANNED AVAILABILITY DATE: END OF AUGUST 2014. ESTIMATED SOFTWARE UPDATE COMPLETION DATE: END OF (B)(4) 2014. THE CORRECTION WILL BE FREE OF CHARGE AND OUR CUSTOMER SERVICE REP WILL CONTACT AFFECTED CUSTOMERS TO SCHEDULE ITS INSTALLATION AS SOON AS THE CORRECTION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE RECORD AND VERIFY SYSTEM ("R&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 TREATMENT/FRACTIONS WHICH ARE COMPLETED AND TO BECOME "TREATED (COMPLETED)" STATUS ON THE EXACT DAY WHEN SUCH CHANGE IS MADE, TO "UNTREATED" STATUS. FURTHERMORE, SUCH TREATMENT PLAN WOULD BE CLONED AND MISTAKENLY ADDED TO THE SCHEDULE AS "UNTREATED" TREATMENT. IF THE CLONED FRACTION WERE TO BE PROVIDED TO THE SAME PT AGAIN, THAT WOULD RESULT IN OVER-DELIVERY OF RADIATION TO THE SAME BODY SITE OF THE PT. ONE OF OUR CUSTOMERS IN (B)(6), (THE "CUSTOMER") PLANNED TO PROVIDE THREE SETS TREATMENT FOR CERTAIN PT (1ST: (B)(6), 2ND: (B)(6), 3RD: (B)(6)). THE IRRADIATED BODY SITE FOR EACH OF THE THREE SETS WAS DIFFERENT. IN (B)(6), AFTER THE COMPLETION OF THE SECOND TREATMENT, THE CUSTOMER CHANGED THE CALENDER SETTING, WHICH CAUSED, DUE TO THE SOFTWARE BUG, FOR A CLONE OF THE SECOND TREATMENT TO BE MISTAKENLY ADDED TO THE SCHEDULE AS "UNTREATED" TREATMENT TO BE PROVIDED IN (B)(6). THE CLONED FRACTION WAS PROVIDED TO THE PT, WHICH CAUSED THE OVER-DELIVERY OF RADIATION TO THE SAME BODY SITE. ACCORDING TO THE CUSTOMER, THE 3RD TREATMENT WAS NOT PROVIDED BY THE PHYSICIAN'S MEDICAL DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403855 MHI-TM2000 LINEAR ACCELERATOR SYSTEM/VERO(TM) MEDICAL LINEAR ACCELERATOR IYE MITSUBISHI HEAVY INDUSTRIES LTD. VER.3.2 LOT #3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other