MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS 1.2T OPEN MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Burning Sensation (2146)

Event Date 12/27/2022

Event Type  malfunction  

Event Description

On january 5, 2023, fujifilm healthcare corporation became aware of an event involving oasis 1.2t open mri system.It was reported that while undergoing a scan of the lumbar spine the patient felt a burning sensation on his arm.The coil cable laid over the patient's arm was repositioned and the scan was completed successfully without harm or injury.There is no death or serious injury associated with the event.As such, this report is being submitted in an abundance of caution.

Manufacturer Narrative

Fujifilm was informed that the coil cable was laid over the patient's arm at the beginning of the exam and the patient complained of the cable heating.The patient experienced temporary redness, lasting less than 5 minutes.The technician repositioned the cable with a towel between the patient and the cable, and the study was completed without further incident.The root cause is determined to be a usage error due to placement of the coil cable over the patient's arm causing direct skin contact.The site was instructed to follow the ifus and related guidelines for proper placement of the patient during imaging scans to prevent similar injuries from occurring.

• Brand Name: OASIS 1.2T OPEN MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 16294701
• MDR Text Key: 308843876
• Report Number: 3018423337-2023-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2012
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 91 KG