MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON OVAL V6.2 MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SYS/MR/ECHELON OVAL 16CH

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Burning Sensation (4540)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

Ref comp # (b)(4).

Event Description

On 12th february 2024 fujifilm healthcare americas corporation was informed of an event involving sys/mr/echelon oval 16ch.It was reported that the patient has a warming issue.The patient showed redness on the right arm.Patient was crammed in the bore and touching the side of the bore due to size.Patient was okay after the exam and no medical treatment was needed.No additional information provided.

• Brand Name: ECHELON OVAL V6.2 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 27708 04; JA 2770804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708-04 ; JA 2770804
• MDR Report Key: 18865488
• MDR Text Key: 337205652
• Report Number: 3018423337-2024-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS/MR/ECHELON OVAL 16CH
• 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: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 350 KG