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 Codes	Unintended System Motion (1430); Failure to Advance (2524); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Crushing Injury (1797); Bone Fracture(s) (1870)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/27/2025, fujifilm healthcare americas corporation became aware of an issue with sys/mr/oasis open+vertex ii.It was reported that the patient table is sticking moving in and out.The table is going in and then stopping.When they press the "set" button they said that the table goes 1-2" further than it should.Customer tried bringing the table "out" and it would come out 1" and then go into release.The customer had to repeat this process multiple times to get it to come out to verify that the table extension latch was not engaged.Customer reported having a patient on the table being seen for an mri of the breast.The malfunction caused the table to jerk the patient forward while entering the manget.Patient stated to the customer that their ribs were broken.The table went in further than the "set" button, but the patient felt crushed as they were inbetween the top of the magnet and the coil.The patient has a buckle fracture of the 6th anterior rib.The fracture was not present prior to the patients mri scan.Patient confirmed to be in tremendous pain.Patient complained further that the machine crushed her back and sternum when it jerked her inside.Patient in taking tylenol 3 to aid with the pain.Patient was released the same date of the injury.This report is being submitted due to the buckle fracture of the 6th anterior rib in the patient.Ref: fujifilm healthcare americas corportation compaint #(b)(4).

• Brand Name: OASIS MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM CORPORATION; 2-1, shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 23597519
• Report Number: 1528028-2025-00001
• Device Sequence Number: 9290457
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025
• Report Date (Section F): 11/19/2025

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?: Yes
• Distributor Facility Aware Date: 10/27/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• 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: 98 KG
• Date Report Sent to FDA: 11/19/2025