MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	H866031
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving with sys/mr/oasis open+vertex ii.It was reported that the c-spine coil was used on a patient on tuesday (b)(6) 2023, and the patient has redness in the chest area.It was later reported that the patient did not seek medical treatment.Patient later confirmed that the redness went away.The coil was not touching the patients chest.There was no death associated with the event.
Additional Manufacturer Narrative
Hcus engineer has talked to the technologist who stated that patient had redness to her chest area.The tech stated that the patient was getting scanned and that her chest was getting hot.Tech stated that she was very claustrophobic.The sagittal images were being scanned.Tech pulled her out of the gantry.She did not complete her study.Patient returned on (b)(6) 23 to complete her study.She had no issues that day, except still feeling claustrophobic.No reaction noted by the patient.She was able to complete the rest of her study.Tech stated that the patient had gone to the dermatologist to get it diagnosed after the incident.Dermatologist told her that it could have been some allergic reaction.

• Brand Name: OASIS MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 18065183
• Report Number: 1528028-2023-00010
• Device Sequence Number: 18082269
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)170202(250)G210004417
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H866031
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 58 KG