MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON OVAL; MAGNETIC RESONANCE DIAGNOSTIC DEVICE.

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On january 06, 2021, fujifilm healthcare americas corporation (formerly hitachi medical systems america, inc.) received a complaint regarding echelon oval mri.The site reported that a patient received a cervical mri on (b)(6) 2020.Since the radiologist were not satisfied with the image quality, patient was rescanned at another facility, using a different system.Prior to this patent was diagnosed with multiple sclerosis on (b)(6) 2018 on an oem system at another site.The patient was scanned on the oem system on (b)(6) 2021.The radiologist used this set of images and compared it to the original images from (b)(6) 2018.The radiologist amended the report from (b)(6) 2020.Patient's condition and treatment information were not released.During a retrospective review, it was discovered that the manufacturer had assessed this event as ae leading to serious injury; therefore an importer's mdr is being submitted.

• Brand Name: ECHELON OVAL
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE.
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 704; JA 277-0704
• MDR Report Key: 13688718
• Report Number: 1528028-2022-00007
• Device Sequence Number: 5009310
• Product Code: LNH
• UDI-Device Identifier: 04580292768391
• UDI-Public: (01)04580292768391(11)171012(250)G200247217
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2021
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2022
• 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