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
Additional Manufacturer Narrative
A medwatch form 3500b was submitted by the customer following the incident.A supplemental report will be submitted pending investigation results.
Event or Problem Description
On september 21, 2022, fujifilm healthcare 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.
Additional Manufacturer Narrative
On november 17, 2022, fujifilm healthcare corporation concluded their root cause investigation on the echelon oval 1.5t mri.There were no issues found with the machine or coils, and the system is operating as intended.Fujifilm believes that the burns were likely caused by the patient's hands touching thereby causing an unintended closed radiofrequency loop.The site was instructed to follow the ifus and related guidelines for proper placement of the patient during imaging scans to prevent similar injuries from occurring.

• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 15610781
• Report Number: 3018423337-2022-00009
• Device Sequence Number: 16831650
• 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
• PMA/510(K) Number: K172110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• 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