BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN LINAC

    MDR report key: 12913779 · Received December 1, 2021

    Report

    Report Number
    3011233554-2021-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 21, 2019
    Report Date
    December 1, 2021
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    UDI-DI
    10868029000305
    PMA / PMN Number
    K170751
    Removal / Correction Number
    30112335544-11-18-19-003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS A RETROSPECTIVE REPORT. A PREVIOUS OCCURRENCE OF THIS ISSUE WAS REPORTED AS MFR REPORT #: 3011233554-2019-00006 AND ASSOCIATED WITH RECALL 30112335544-11-18-19-003-C. THIS ISSUE WAS IN THE RECALL BUT WAS NOT INDIVIDUALLY REPORTED AS AN MDR. THE RECALL FOR THIS ISSUE HAS BEEN COMPLETED AND A SOFTWARE PATCH WAS RELEASED. VIEWRAY HAS NOT RECEIVED A CUSTOMER REPORT OF INCORRECT DOSE APPLICATION OR SIGNIFICANT DELAY IN TREATMENT DUE TO THIS ISSUE.

    Description of Event or Problem · 0

    A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN OCCURRENCE IN THE PLANNING/FUSION WORKFLOW WHERE: 1. MANUAL TRANSLATION SHIFT CANNOT BE APPLIED CORRECTLY TO SECONDARY DOSE VOLUME WHEN SECONDARY DOSE AND SECONDARY CT COMES FROM OTHER VENDOR A. MANUALLY ALIGN SECONDARY CT AND PRIMARY MRI. B. APPLY THE SAME TRANSLATION VALUE TO THE SECONDARY DOSE WHICH IS ASSOCIATED TO THE CT. C. OBSERVED THAT SECONDARY DOSE VOLUME IS NOT ALIGNED WITH PRIMARY MRI AND REGISTERED CT. 2. MANUAL TRANSLATION SHIFT CANNOT BE APPLIED CORRECTLY TO SECONDARY DOSE VOLUME WHEN SECONDARY DOSE AND SECONDARY MRI GENERATED FROM MRIDIAN SYSTEM BUT AT A DIFFERENT FOV COMPARED TO PRIMARY MRI. A. MANUALLY ALIGN SECONDARY MRIDIAN MRI AND PRIMARY MRIDIAN MRI. B. APPLY THE SAME TRANSLATION VALUE TO THE SECONDARY DOSE WHICH IS ASSOCIATED TO THE SECONDARY MRIDIAN MRI. C. OBSERVED THAT SECONDARY DOSE VOLUME IS NOT ALIGNED WITH PRIMARY MRI AND REGISTERED MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810282 MRIDIAN LINAC RADIATION THERAPY IYE VIEWRAY, INC. 20000 10868029000305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown