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

Model Number N/A

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Fujifilm conducted a root cause investigation for this event.No malfunction was identified during investigation.Therefore, root cause was not established.As a safety measure, fujifilm will continue to monitor the site.

Event Description

On (b)(6) 2022, fujifilm healthcare corporation received a complaint regarding oasis xp 1.2t open mri system.It was reported that the patient felt a burning sensation while undergoing a scan of the lumbar spine.The patient did not complain of any burning sensation during the first portion of the scan, but before being injected with contrast, the patient stated she felt a burning sensation and warmness on her back.Upon examination, the radiologist observed that the affected area was warm to the touch.However, there was no report of visible blistering/redness and burns or serious injury to the patient.There is no death or serious injury associated with event.This event is being 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
• 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: 14713750
• MDR Text Key: 301276696
• Report Number: 3018423337-2022-00007
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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: 05/27/2022
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 84 KG