MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRX SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	105828-000
Medical Device Problem Codes	Output Problem (3005); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation indicates the mri magnet was producing an error message for gradient temperature too high in conjunction with the shutdown of the scanning sequences.Imris is following up with manufacturer to confirm cause.Two boards and a fiber optic cable running between the boards were replaced and restored mri functionality.No imris components are believed to have contributed to the malfunction based on on-site assessment.Detailed information was collected from the customer on 2024-08-23 after multiple attempts to gather patient and procedure information; no patient demographic information was provided.
Event or Problem Description
The customer reported that during an mr-guided ablation treatment for temporal lobe tumor, the mri scanner would not function.The customer reported the target was established, laser probe inserted in the cranial bolt fixation ready for thermo-therapy when scans kept aborting.The scanner would run 40 secs then abort.All attempts were exhausted by the neurosurgeon who after four hours decided to reschedule the treatment for the following week.Intra-op and post-op scans were inclusive regarding therapy to targeted area.The cusotmer reported there was no adverse outcome to the patient who was discharged the following day with an appointment to return the next week for additional treatment.
Additional Manufacturer Narrative
The cause was traced to two i/o boards, which were replaced by third-party mri manufacturer and restored mri functionality.Imris made multiple attempts over phone and email to gather patient demographic information, while demographic information was not provided it was reported there was no adverse outcome to the patient.This report encompasses udi related data quality updates to match brand name and udi with gudid data.

• Brand Name: IMRX SYSTEM
• 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: 20058884
• Report Number: 3010326005-2024-00007
• Device Sequence Number: 8357271
• Product Code: LNH
• UDI-Device Identifier: 00857534006165
• UDI-Public: (01)00857534006165(11)20121112
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091166
• 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): 08/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 105828-000
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2024
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2012
• 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 Sex: Unknown