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 americas 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.

• 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
• MDR Report Key: 17396224
• MDR Text Key: 319838525
• Report Number: 1528028-2023-00006
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other