BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVION S250I

    MDR report key: 19370411 · Received May 22, 2024

    Report

    Report Number
    3007087027-2024-00002
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 21, 2024
    Manufacturer
    MEVION MEDICAL SYSTEMS, INC.
    Product Code
    LHN
    UDI-DI
    00864366000124
    PMA / PMN Number
    K172848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE PATIENT PLAN WAS LOADING INTO THE PATIENT REGISTRATION APPLICATION ('VERITY'), COMMUNICATIONS BETWEEN THE REGISTRATION APPLICATION AND THE TREATMENT DELIVERY CONSOLE WERE INTERRUPTED. BEFORE THE INTERRUPTION, VERITY WAS ONLY ABLE TO LOAD APPROXIMATELY HALF OF THE PLANNING CT SLICES AND LOGGED AN ERROR. VERITY DOES NOT LOAD THE SLICES IN A SEQUENTIAL ORDER, AND BECAUSE OF THE COMMUNICATIONS DISRUPTION DURING THE DATA TRANSFER, THIS INTRODUCED GAPS IN THE CT DATASET. VERITY INTERPOLATED TO COVER THE MISSING SLICES, AND THIS CAUSED THE GENERATION OF ELONGATED CONTOURS. THESE ELONGATED CONTOURS WERE THEN USED TO ALIGN THE PATIENT FOR TREATMENT, LEADING TO A MISALIGNMENT. COMMUNICATIONS BETWEEN VERITY AND THE TREATMENT DELIVERY SYSTEM WERE RE-ESTABLISHED WHILE THE PATIENT WAS STILL LOADED, CAUSING THESE NEWLY GENERATED, ELONGATED CONTOURS TO BE SAVED AND ALSO USED FOR THE SUBSEQUENT DELIVERY FRACTION. CLEARING THE CACHE OF THE INCORRECTLY GENERATED CONTOURS FORCED VERITY TO REGENERATE CONTOURS, THIS TIME FROM A FULL CT DATA SET. THIS RESOLVED THE ISSUE FOR THIS PATIENT'S REMAINING DELIVERY FRACTIONS. A SOFTWARE CHANGE WILL BE IMPLEMENTED TO HAVE THE SYSTEM REPORT AN ERROR IF THE DATA TRANSFER IS INTERRUPTED INSTEAD OF TRYING TO GENERATE CONTOURS WITHOUT THE MISSING CT SLICES. A REQUIREMENT FOR THIS WILL BE ADDED TO THE SYSTEM REQUIREMENTS DOCUMENT, AND THIS WILL BE A NEW, ADDITIONAL MITIGATION IN THE SUBSYSTEM HAZARD ANALYSIS. MEVION HAS ALSO PERFORMED A LOGFILE ANALYSIS AND DETERMINED THAT AN EVENT SUCH AS THIS ONE HAS OCCURED TWICE PREVIOUSLY, BUT ONLY EVER ON THIS PARTICULAR MACHINE. THIS PARTICULAR MACHINE HAS AN OPEN IT TICKET WITH THE HOSPITAL'S IT STAFF TO ADDRESS ONGOING DATA COMMUNICATIONS ISSUES.

    Description of Event or Problem · 0

    DURING TREATMENT OF PATIENT (B)(6) ON (B)(6) 2024, THERAPISTS NOTED THAT CONTOURS LOOKED ELONGATED ON PATIENT IMAGES, BUT PROCEEDED WITH ALIGNMENT AND TREATMENT. CONTOURS LOOKED AS EXPECTED (NOT ELONGATED) IN OFFLINE REVIEW. PATIENT (B)(6) WAS THE ONLY PATIENT WITH THIS ISSUE, NO OTHER PATIENTS ON (B)(6) HAD THIS ISSUE. WHEN SETTING UP THIS PATIENT ON (B)(6), THERAPISTS NOTED THAT CONTOURS WERE ELONGATED AGAIN. AFTER TREATING, THE PATIENT IMAGES WERE LOOKED AT IN OFFLINE REVIEW AND THE CONTOURS ONCE AGAIN APPEARED AS EXPECTED. THERAPISTS EXPRESSED CONCERNS OF A MISALIGNMENT DUE TO THE ELONGATED CONTOURS. PHYSICIAN REVIEW OF THE RECORDS SHOWED THAT TWO SEPARATE FRACTIONS WERE MISALIGNED, FRACTIONS ON BOTH THE 24TH AND 25TH. THE FIRST FRACTION WAS MISALIGNED BY 0.72CM AND 0.83CM, AND THE SECOND FRACTION WAS MISALIGNED BY 1.3CM AND 1.5CM. NO HARM OR PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788704 MEVION S250I LHN MEVION MEDICAL SYSTEMS, INC. MEVION S250I N/A 00864366000124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown