BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINEMAVISION GOGGLES

    MDR report key: 23821783 · Received December 16, 2025

    Report

    Report Number
    23821783
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 2, 2025
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MRI VIDEO SYSTEM GOGGLES WERE RESTING ON PATIENTS FACE/NOSE, AND HE SUSTAINED A THERMAL BURN FROM THE GLASSES. THEY HAD PARTIALLY COME OFF HIS FACE WHEN THE TABLE MOVED MAKING THEM CROOKED AND THE NOSE PIECE WAS RESTING UNCOMFORTABLY ON HIS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039731 CINEMAVISION GOGGLES SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH RESONANCE TECHNOLOGY, INC. CV2020

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other