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

Model Number SYS/MR/ECHELON OVAL 32CH

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Burning Sensation (2146); Skin Burning Sensation (4540)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Ref comp #(b)(4).

Event Description

On january 26th 2024 fujifilm healthcare americas corporation was informed of an event involving sys/mr/echelon oval 32ch.It was reported that the customer mentioned patient warming when speaking about the lumbar/prostate/hip issues they've been having lately.Tech mentioned the connectors in the table are loose and consistently need to be tightened by the techs.Customer also mentioned a few different patients, none by specifics to coil/study or even by name.She mentioned the warming sensations were only mentioned, patients experienced no pain - only minor discomforts, symptoms resolved each time before the patient left the facility, and there were no incidents that required follow-on attention.No patients had visible signs of redness.There was no harm or injury to the patient.No additional information provided.

• Brand Name: ECHELON MRI IMAGING SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708 04; JA 2770804
• MDR Report Key: 18743766
• MDR Text Key: 335813527
• Report Number: 1528028-2024-00005
• 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: 02/05/2024,02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYS/MR/ECHELON OVAL 32CH
• Device Catalogue Number: N/A
• Device Lot Number: Y054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1