BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINEMAVISION GOGGLES

    MDR report key: 13839140 · Received March 21, 2022

    Report

    Report Number
    13839140
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 3, 2022
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S - PATIENT IN MRI RECEIVED A CUT TO HER LEFT UPPER AND LOWER EYE LID WHILE WATCHING MOVIE THROUGH GOGGLES IN MRI. B - PATIENT WAS SCREENED FOR ANY METAL THEN SCANNED BEFORE BEING BROUGHT INTO MRI SCANNER. PATIENT IS AN ADOLESCENT FEMALE WHO HAS HAD MRIS WITH US BEFORE. PATIENT WAS SET UP WITH MOVIE HEADPHONES AND GOGGLES AS WE NORMALLY DO. PATIENT WAS PUT INTO THE SCANNER AND 2 LOCALIZER IMAGES WERE OBTAINED. AT THIS POINT WE NOTICED THE PATIENT TOUCHING HER FACE; SO WE ASKED THROUGH THE HEADPHONES IF SHE WAS OKAY. SHE STATED IT FELT LIKE SOMETHING HIT HER IN THE EYE. WE IMMEDIATELY WENT INTO THE SCAN ROOM TO PULL HER OUT OF THE SCANNER AND INVESTIGATE. PATIENT BECAME EMOTIONAL AND UPSET AND WE NOTICED A SMALL CUT ON HER UPPER AND LOWER LEFT EYELID. PATIENT WAS REMOVED FROM THE SCANNER AND BROUGHT TO HER MOTHER AND GIVEN A COLD BOTTLE OF WATER FOR HER EYE. A - WE ASSESSED THE MOVIE GOGGLES AND DID NOT NOTICE ANY VISIBLE DAMAGE TO MOVIE GOGGLES. GOGGLES WERE USED TODAY ALREADY ON PREVIOUS PATIENT WITH NO ISSUES. WE LOOKED INSIDE THE SCANNER FOR ANY VISIBLE METAL THAT COULD HAVE INJURED HER AND FOUND NOTHING. RADIOLOGY MANAGER CAME TO ASSIST WITH THE PATIENT AND INVESTIGATE AND ALSO DISCOVERED NOTHING. HE CONTACTED THE COMPANY THAT PROVIDES US WITH THE MOVIE SYSTEM AND SUBMITTED A REPORT WITH THEM. R - AFTER SUBMITTING THE REPORT WITH THE MOVIE SYSTEM COMPANY WE REMOVED THE MOVIE GOGGLES FROM THE SYSTEM AND WILL BE SENDING THEM TO THE COMPANY FOR INVESTIGATION. PER MY MANAGER WE ARE TO RESUME SCANNING AS NORMAL BUT WITH NO MOVIE GOGGLES. THE RESONANCE TECHNOLOGY MOVIE VISOR (CINEMAVISION GOGGLES) WERE PLACED OVER THE PATIENT'S EYES TO DISPLAY A MOVIE DURING HER MRI PROCEDURE. AFTER COMPLETING THE LOCALIZER THE PATIENT COMPLAINED THAT HER EYE HAD BEEN CUT. WHEN SHE WAS REMOVED FROM THE SCANNER THE GOGGLES WERE EVALUATED AND NOTHING SHARP WAS FOUND. NO EXPOSED WIRES, SHARP MATERIALS, NOTHING. THE GOGGLES SEEMED COMPLETELY NORMAL. THE MANUFACTURER WAS IMMEDIATELY CALLED AND THE DEVICE WAS REMOVED FROM SERVICE. THE PATIENT COMPLAINED IT FELT LIKE A LASER. RESONANCE TECHNOLOGY IS IN POSSESSION OF THE GOGGLES AND WILL REPORT BACK ONCE THEY'VE INVESTIGATED.  PATIENT DIDN'T HAVE ANY FACIAL IMPLANTS, DEVICES, OR EXTERNAL MAKEUP OF ANY KIND. THE PATIENT/PARENT REPORTED, SHE NEVER WORKED WITH METAL OR HAS HAD METAL IN THE EYES.  THE GOGGLES CAUSED A CUT/BURN TO THE PATIENT. UNKNOWN AT THIS TIME HOW THIS HAPPENED. DEVICE DID NOT SEEM DEFECTIVE. DEVICE REMOVED FROM USE AND SENT TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545209 CINEMAVISION GOGGLES SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH RESONANCE TECHNOLOGY, INC. RTC550

    Patients

    Seq Age Sex Outcome Treatment
    1 3650 DA Female