BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGNRT PLUS

    MDR report key: 12156820 · Received July 13, 2021

    Report

    Report Number
    3004832819-2021-90001
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 12, 2021
    Manufacturer
    VISION RT LTD
    Product Code
    IYE
    UDI-DI
    05056190500481
    PMA / PMN Number
    K203387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO THE MANUFACTURER AS A BEAM HOLD FAILURE. INVESTIGATION OF THE LOGS PERTAINING TO THE INCIDENT SHOW THAT ALIGNRT WAS SET UP WITH A 2-SECOND DELAY TO HOLDING THE BEAM. ACCORDINGLY, ALIGNRT STARTED A 2-SECOND COUNTDOWN TO BEAM HOLD WHEN THE PATIENT MOVED OUT OF PRE-DEFINED TOLERANCES. THE OPERATOR WAS ALERTED BY ALIGNRT TO THE PATIENT MOVING OUT OF TOLERANCE AND THE OPERATOR MANUALLY HELD THE BEAM WITHIN THE COUNTDOWN TIMEFRAME. ALIGNRT PERFORMED AS INTENDED AND REMOTE INSPECTION SHOWS THAT IT CONTINUES TO PERFORM TO SPECIFICATION. NO HARM WAS REPORTED TO THE PATIENT OR USER. THE INCIDENT IS NOT REPORTABLE AS THERE WAS NO ADVERSE EVENT (HARM) OR POTENTIAL TO CAUSE AN ADVERSE EVENT IF THE INCIDENT OCCURRED AGAIN. HOWEVER, THE MANUFACTURER DECIDED TO FILE A REPORT DUE TO THE NATURE OF THE INITIAL REPORT FROM THE USER FACILITY.

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING RADIOTHERAPY ON AN ELEKTA SYNERGY LINEAR ACCELERATOR. ALIGNRT WAS SET UP TO AUTOMATICALLY HOLD THE BEAM OF THE LINAC IF THE PATIENT MOVED OUT OF PRE-DEFINED TOLERANCES FOR MORE THAN TWO (2) SECONDS. THE PATIENT'S ROLL DELTA MOVED OUT OF TOLERANCE. ALIGNRT STARTED THE 2 SECOND COUNTDOWN TO BEAM HOLD. THE DELTAS SHOWED ON THE SCREEN AND THE OPERATOR MANUALLY HELD THE BEAM AFTER ONE (1) SECOND. THE OPERATOR REPORTED THE MANUAL INTERVENTION TO THE MANUFACTURER AS A BEAM HOLD FAILURE, AS THEY HAD EXPECTED ALIGNRT TO AUTOMATICALLY HOLD THE BEAM AFTER ONE (1) SECOND. THE SAME CENTRE REPORTED A RECURRENCE OF THE INCIDENT ON A DIFFERENT PATIENT THE NEXT DAY ((B)(6) 2021) AND A PREVIOUS INCIDENT THE MONTH BEFORE (NOT PREVIOUSLY REPORTED TO THE MANUFACTURER). THERE WAS NO HARM REPORTED TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059612 ALIGNRT PLUS ALIGNRT IYE VISION RT LTD 6.3.0 05056190500481

    Patients

    Seq Age Sex Outcome Treatment
    1