BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN LINAC

    MDR report key: 12913780 · Received December 1, 2021

    Report

    Report Number
    3011233554-2021-00003
    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
    PMA / PMN Number
    K170751
    Removal / Correction Number
    30112335544-11-18-19-003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    DURING INTERNAL TESTING VIEWRAY IDENTIFIED THAT UNDER CERTAIN CIRCUMSTANCES THE PREVIOUSLY DELIVERED DOSE MAY NOT BE CORRECTLY DISPLAYED WHEN PLAN POSITION IS IN THE HEAD-FIRST-PRONE (HFP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810283 MRIDIAN LINAC RADIATION THERAPY IYE VIEWRAY, INC. 20000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown