MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SYS/MR/OASIS OPEN+VERTEX II

Device Problem Insufficient Information (3190)

Patient Problem Radiation Burn (1755)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

Ref (b)(4).

Event Description

On january 18th 2024 fujifilm healthcare americas corporation was informed of an event involving sys/mr/oasis open+vertex ii and x-large flex coil.It was reported that a patient complained of feeling of burning on her stomach using x-large flex coil halfway through a sag stir sequence on her spine.This was the 3rd series in the study.The technologist put a pad between the patient and the coil, and started the sequence again.Again, the patient pressed the call switch because she felt a burning sensation.The patient was removed.The area that the patient complained of burning was above the belly button.A gown was only thing the patient was wearing and was the only thing between the patient and the coil besides the pad that was added.The tech did not notice any heating from the coil.Tech states patient's stomach was a bit red.The doctor checked the patient, the area was red with no serious injury and no treatment was given.No additional information provided.

Manufacturer Narrative

Ref comp #(b)(4).From fpr and incident report, investigation report, receiver coil performance tests were within specification and the heat generation test is no problem.Based on the above results, fhc conclude that there are no problems with the mri system and receiver coil.The patient setting and the system operation were no problem.

• Brand Name: OASIS MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708 04; JA 2770804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708 04; JA 2770804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708-04 ; JA 2770804
• MDR Report Key: 18668545
• MDR Text Key: 334906146
• Report Number: 3018423337-2024-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS/MR/OASIS OPEN+VERTEX II
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1