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

Model Number	OASIS
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/31/2025, fujifilm corporation was informed of an event involving sys/mr/oasis open+vertex ii.It was reported that the cable for the patient call switch has burned.The malfunction occurred during the procedure.No injury was reported.The switch was still operable, though the site was asked not to use it until they addressed the issue.Since the burn was significant enough to melt plastic and left a mark on the table, there is a potential the cable could have burned the patient.Due to the potential risk of burn to patient, fujifilm corporation is reporting this event in an abundance of caution.
Additional Manufacturer Narrative
A supplemental report will be submitted pending investigation results.

• Brand Name: OASIS
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM CORPORATION; 2-1, shintoyofuta; kashiwa-shi chiba, 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM CORPORATION; 2-1, shintoyofuta; kashiwa-shi chiba, 277-0 804; JA 277-0804
• Manufacturer Contact: 2-1, shintoyofuta; kashiwa-shi chiba, 277-0-804
• MDR Report Key: 21455628
• Report Number: 3018423337-2025-00001
• Device Sequence Number: 20781718
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)170313(250)G210017917
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown