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  malfunction  

Manufacturer Narrative

Fujifilm healthcare corporation conducted a root cause investigation and concluded their findings on (b)(6) 2022.The system is performing as intended and a definitive root cause for the reported issue could not be established.The scans were reportedly performed back to back without any pause/breaks.It is recommended to align the scans but pause between each scan for reconstruction to occur.This will allow the patient's body to cool between sequences.During mr examinations, a patient's temperature is expected to rise due to the absorption of rf energy.Depending on size, pulse sequence, and interaction, temperature variations are likely to occur in patients.Therefore, it is recommended to perform routine monitoring during procedures and pay special attention to patients that may be sensitive to high rf energy.Furthermore, it is required to ensure proper ventilation and that the patients wear light clothing while scanning is being performed as described in the operation manual.As such, while the back to back scans may have been a contributing factor, it cannot be concluded that it was the root cause of the patient's temperature rise.

Event Description

On (b)(6) 2022, fujifilm healthcare corporation was notified of an adverse event involving 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.There was no report of any burns or serious injury to the patient.There is no death associated with the event.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
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: katsuyuki minagawa ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 14603178
• MDR Text Key: 301114808
• Report Number: 3018423337-2022-00005
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female