MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON OVAL 1.5T MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On september 16, 2022, fujifilm healthcare americas corporation became aware of an event involving echelon oval 1.5t mri system that occurred on (b)(6) 2022.It was reported that while undergoing an mri of the spine the patient experienced a burning sensation on her arms and suffered blistering on her hands.There is no death associated with this event.

• Brand Name: ECHELON OVAL 1.5T MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 15477652
• Report Number: 1528028-2022-00060
• Device Sequence Number: 12263563
• Product Code: LNH
• UDI-Device Identifier: 04580292768391
• UDI-Public: (01)04580292768391(11)170810(250)G200197317
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2022
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2022
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White