MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON XL 1.5T MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number N/A

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/27/2023

Event Type  Injury  

Event Description

On (b)(6), 2023, fujifilm healthcare corporation became aware of an event involving echelon xl 1.5t mri system.It was reported that the patient felt a warming sensation on their neck during a ctl study.Following the scans, the patient was sweating profusely and had visible redness.However, no medical treatment or surgical intervention was required and the study was completed without further incident.There was no death associated with the event.

Manufacturer Narrative

A supplemental report will be submitted pending investigation results.

Manufacturer Narrative

On august 29, 2023, fujifilm healthcare corporation concluded the root cause investigation.The root casuse of the reported issue was not determined.Reciever coil performance tests were within specification and the heat generation test showed no problems.The patient setttings also showed no problems.The site is being monitored.

• Brand Name: ECHELON XL 1.5T 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: 17396183
• MDR Text Key: 319839000
• Report Number: 3018423337-2023-00006
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 103 KG