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	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 fujifilm healthcare americas corporation received a complaint regarding oasis xp 1.2t open mri system.The customer complained about the quality of breast imaging.The patient is a known breast cancer patient and is actively undergoing treatment.The site reported the discrepancy in the size of a lesion that was 75 mm on a non-fujifilm system (scan was done on (b)(6) 2022) vs only 5 mm on the oasis xp 1.2t open mri system (scan was done on (b)(6) 2022).There is no death or serious injury associated with event.As such, this is being submitted in an abundance of caution.

• 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
• MDR Report Key: 14841271
• Report Number: 1528028-2022-00048
• Device Sequence Number: 11970191
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)190508(250)G210035619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2022
• Device Age: 37 MO
• Event Location: Outpatient Diagnostic Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female