MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS IMRI 3T V; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	120823-000
Medical Device Problem Codes	Image Display Error/Artifact (1304); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris service engineer investigated the reported artifact on-site and was not able to reproduce the artifact.The imris magnetic resonance safety officer reviewed images provided and confirmed presence of broadband arifact.Based on followup communications the artifact has recently appeared intermittently and is most likely associated with a light source within the operating room that remained on during scanning, introducing rf noise.Third-party manufacturer of the mri magnet and imaging coils was engaged and has not identified a product malfunction while on-site.If any further reportable information is received a follow-up report will be submitted.This event was reported due to the length of procedural delay under anesthesia reported by the end user, no injuries to the patient were reported.
Event or Problem Description
The customer reported that during intra-operative imaging in the operating room, a major broadband radiofrequency artifact presented during mr scanning after the magnet was advanced to imaging location in the operating room.The rf noise prevented the diagnostic images from being clinically useful.The patient was taken out of the skull pins and transported to the diagnostic room for scanning, which was completed successfully.The customer reported there was no harm or injury to the patient; however a delay greater than 60 minutes occurred and additional medication and monitoring were required during the modification to the planned imaging portion of the procedure.
Additional Manufacturer Narrative
A third-party imaging coil was also identified as producing low signal to noise ratio results and could have contributed to the broadband rf noise reported; this coil was replaced.Updated mdr coding is being submitted to reflect probable causes as light source in the or and imaging coil performance.Troubleshooting has not identified a further potential contributor to the intermittent rf noise, which appears to be resolved.

• Brand Name: IMRIS IMRI 3T V
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 19397827
• Report Number: 3010326005-2024-00006
• Device Sequence Number: 7762193
• Product Code: LNH
• UDI-Device Identifier: 00857534006745
• UDI-Public: (01)00857534006745
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 120823-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 19 KG