BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINEMAVISION AUDIO/VIDEO MRI SYSTEM

    MDR report key: 14106563 · Received April 13, 2022

    Report

    Report Number
    2029299-2022-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 31, 2022
    Manufacturer
    RESONANCE TECHNOLOGY INC
    Product Code
    LNH
    PMA / PMN Number
    K994351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED DAMAGED FROM COMPLAINANT AND WAS SCRAPPED DUE TO IRREPARABLE DAMAGE TO VIEWING OPTIC.

    Description of Event or Problem · 0

    PATIENT DURING MRI SCAN RECEIVED A SKIN ABRASION ON THE UPPER AND LOWER EYE LID WHILE UTILIZING THE CINEMAVISION VISOR GOGGLES. PATIENT WAS SCREENED FOR ANY METALS BEFORE BEING BROUGHT INTO MRI SCANNER. PATIENT IS AN ADOLESCENT FEMALE WHO HAS HAD MRI SCANS BEFORE. PATIENT WAS SET UP WITH MOVIE HEADPHONES AND GOGGLES AS NORMALLY DONE AT CUSTOMER SITE. PATIENT WAS PUT INTO THE SCANNER AND 2 LOCALIZER IMAGES WERE OBTAINED. AT THIS POINT, MRI RADIOLOGIST NOTICED THE PATIENT TOUCHING HER FACE. SHE STATED IT FELT LIKE SOMETHING HIT HER IN THE FACE. SCAN WAS IMMEDIATELY STOPPED WAS WAS PULLED HER OUT OF THE SCANNER TO INVESTIGATE. THE GOGGLES WERE EVALUATED AND NOTHING SHARP WAS FOUND. NO EXPOSED WIRES, SHARP MATERIALS, NOTHING. THE GOGGLES SEEMED COMPLETELY NORMAL. PATIENT BECAME EMOTIONAL AND UPSET SO MRI TECHNICIAN NOTICED A SMALL ABRASION 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. PATIENT RESUME SCANNING AS NORMAL BUT WITH NO MOVIE GOGGLES. MOVIE GOGGLES WERE ASSESSED BY MRI RADIOLOGIST AND MRI SUPERVISOR AND DID NOT NOTICE ANY VISIBLE DAMAGE TO MOVIE GOGGLES. GOGGLES WERE USED PREVIOUSLY ON THE SAME DATE WITH DIFFERENT PATIENT WITH NO ISSUES. MRI SUPERVISOR LOOKED INSIDE THE SCANNER FOR ANY VISIBLE METAL THAT COULD HAVE INJURED HER AND FOUND NOTHING. MRI MANAGER CAME TO ASSIST WITH THE PATIENT AND INVESTIGATE AND ALSO DISCOVERED NOTHING. RESONANCE TECHNOLOGY INC WAS CONTACTED TO SUBMIT A COMPLAINT AND IMMEDIATELY REMOVED THE MOVIE GOGGLES FROM THE SYSTEM. GOGGLE VISOR RETURNED TO THE MANUFACTURE FOR INVESTIGATION. UNKNOWN AT THIS TIME HOW THIS HAPPENED. DEVICE DID NOT SEEM DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899914 CINEMAVISION AUDIO/VIDEO MRI SYSTEM GOGGLES VISOR LNH RESONANCE TECHNOLOGY INC RTC550

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female