MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fujifilm is performing additional investigation to determine the root cause.A supplemental report will be submitted pending results of the investigation.
Event or Problem Description
On 03 march 2022, fujifilm healthcare corporation received a complaint regarding oasis xp 1.2t open mri system.It was reported that a (b)(6) patient complained that the scanner was really loud and had a smell to it.He called back the day after the scan stating that his ears were still ringing.The patient was concerned if the machine was working properly.No additional information was provided.There is no death or serious injury associated with event.This event is being reported in an abundance of caution.
Additional Manufacturer Narrative
On june 09, 2022, fujifilm healthcare concluded the root cause investigation.During the investigation, the following was noted: the examination was completed successfully and there was no delay noted.There were no problems reported with the images taken.The sound pressure level was less than 140db, complying with the standards.There were no user lead errors identified.There were no problems reported with the device before and after this event/scan.The device was inspected and found to be performing as intended.There were no abnormalities identified within the device that could have led to this event.

• Brand Name: OASIS XP 1.2T OPEN MRI SYSTEM
• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 704; JA 277-0704
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-704 ; JA 277-0704
• MDR Report Key: 14084517
• Report Number: 3018423337-2022-00002
• Device Sequence Number: 2121464
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)200515(250)G210031120
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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
• Patient Age: 28 YR
• Patient Sex: Male