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

Model Number	ECHELON OVAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is currently ongoing.The information currently available is as follows.1.We have received reports from medical technicians that the patient had many medical problems.2.There were no device error logs.3.We have received reports that the device was operating normally.
Event or Problem Description
On may 29th, 2025, fujifilm corporation was informed of an event involving echelon oval mri system.Patient has died while being scanned for abdomen on echelon oval mri system.
Additional Manufacturer Narrative
On june 25, 2025, a report was received from the importer stating that there were no issues with the image quality of the device.We determined that the device was operating normally because there were no device error logs and there were no image quality issues.

• Brand Name: ECHELON OVAL MRI SYSTEM
• 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
• MDR Report Key: 22181956
• Report Number: 3018423337-2025-00004
• Device Sequence Number: 8617394
• Product Code: LNH
• UDI-Device Identifier: 04573596200773
• UDI-Public: (01)04573596200773(11)221115(250)G200194922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: ECHELON OVAL
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 12/08/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG