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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Tinnitus (2103)

Event Date 04/15/2022

Event Type  malfunction  

Event Description

On april 28, 2022, fujifilm healthcare corporation received a complaint regarding the oasis xp 1.2t open mri system.It was reported that a female patient complained of ringing in the left ear following a lower extremity scan.During the scan, the patient was wearing headphones and listening to jazz music.The technician confirmed that the patient could hear the music at the time of the scan.The patient stated that she did not notice the ringing until she was home.No hearing loss was reported and no further information was provided.There is no death or serious injury associated with the event.As such, this report is being submitted in an abundance of caution.

• Brand Name: OASIS XP 1.2T OPEN MRI SYSTEM
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 14489913
• MDR Text Key: 293085811
• Report Number: 1528028-2022-00038
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)191015(250)G210090219
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 04/28/2022
• Device Age: 31 MO
• Event Location: Outpatient Diagnostic Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female