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

Model Number	SYS/MR/OASIS OPEN+VERTEX II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05/29/2026, fujifilm healthcare americas corporation became aware of an event involving sys/mr/oasis open+vertex ii.The customer reported that another patient complained of heating and an electrical shock feeling in her right hand after running the scanogram.The patient #3 completed both studies, lumbar then head.The patient #3 did not seek any additional medical attention.Fuji engineer has completed the transmitter testing and temperature testing.On 06/26/2026, fujifilm healthcare americas corporation determined not to submit an importer mdr since the patient #3 completed both studies.Due to the complaint of heating and an electrical shock feeling in patient's right hand, fujifilm healthcare americas corporation has determined on 07/01/2026 to submit an importer mdr of this event in an abundance of caution.Related: patient 1 - 1000513161-2026-00012.Patient 2 - 1000513161-2026-00013.Ref: fujifilm healthcare americas corporation complaint # (b)(4).

• Brand Name: OASIS MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 25685762
• Report Number: 1000513161-2026-00014
• Device Sequence Number: 15867081
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)180619(250)G210059218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/01/2026

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: SYS/MR/OASIS OPEN+VERTEX II
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• 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: Unknown