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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burning Sensation (2146)

Event Date 03/16/2022

Event Type  Injury  

Event Description

On march 16, 2022, fujifilm healthcare americas corporation received a complaint regarding the oasis xp 1.2t open mri system.It was reported that the patient felt very hot and broke out in a sweat during a pelvic exam prior to being given contrast.The sensation dissipated within 5 minutes of the scan ending.It is recommended to align the scans but pause in between each scan for reconstruction to take place.This will allow the patient's body to cool between sequences.Instead, the scans were reportedly performed back to back without any pause/breaks.There was no report of any burns or serious injury to the patient.There is no death associated with the event.This issue was initially identified as a non-reportable event.During a retrospective review, it was determined that this complaint should be reported 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: 14382074
• MDR Text Key: 293716692
• Report Number: 1528028-2022-00039
• Device Sequence Number: 1
• Product Code: LNH
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/14/2022
• Event Location: Outpatient Diagnostic Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female