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

Model Number SYS/MR/ECHELON XL 1.5T

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

On february 20, fujifilm healthcare americas corporation was informed of an event involving sys/mr/echelon xl 1.5t it was reported that the x gradient lead burned open at the rear of the gantry.It was later confirmed that there was a patient on the table when the gradient lead burned open.Tech got the patient off the table without incident.The imaging was not completed on this scanner but the tech had to move this exam to the other mri unit.There was no harm or injury to the patient.

Manufacturer Narrative

Ref comp# (b)(4).

Manufacturer Narrative

Ref comp# (b)(4).

Event Description

On february 19th, fujifilm healthcare americas corporation was informed of an event involving sys/mr/echelon xl 1.5t it was reported that the x gradient lead burned open at the rear of the gantry.It was later confirmed that there was a patient on the table when the gradient lead burned open.Tech got the patient off the table without incident.The imaging was not completed on this scanner but the tech had to move this exam to the other mri unit.There was no harm or injury to the patient.

• Brand Name: SYS/MR/ECHELON XL 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken
• 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: 18921802
• MDR Text Key: 337874618
• Report Number: 3018423337-2024-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYS/MR/ECHELON XL 1.5T
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1