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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 12/09/2022

Event Type  Injury  

Event Description

On december 9, 2022, fujifilm healthcare americas corporation became aware of an event involving echelon xl 1.5t mri system.It was reported that while undergoing an mri of the left hand the patient sustained 1st degree burns on her hand.The patient's burns were treated by an on-site nurse and no additional treatment or surgical intervention was required.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: 16112906
• MDR Text Key: 306807799
• Report Number: 1528028-2023-00001
• 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: 01/06/2023

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/09/2022
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 67 KG