MAUDE Adverse Event Report: RESONANCE TECHNOLOGY, INC. CINEMAVISION GOGGLES; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number RTC550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: CINEMAVISION GOGGLES
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): RESONANCE TECHNOLOGY, INC.; 18121 parthenia st.; northridge CA 91325
• MDR Report Key: 13839140
• MDR Text Key: 287536129
• Report Number: 13839140
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RTC550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Sex: Female