MAUDE Adverse Event Report: IMRIS IMAGING, INC IMRI 3T S; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	116118-000
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no device malfunction.The patient was being transported into the mri diagnostic room by a hospital employee via a ferrous wheelchair at the time of the event.It is unknown if the hospital employee was trained to bring patients into the mri diagnostic room (zone 4), and it is also unknown if the wheelchair had appropriate or inappropriate astm labeling.Imris has requested more information regarding the event and the patient involved multiple times with no response back from the customer.The information received regarding the patient outcome was provided by the imris customer service engineer.There was no reported serious harm or injury to the patient from this event.Imris will submit a follow-up report if additional information becomes available.
Event or Problem Description
The patient was transported into the mri diagnostic room (zone 4) by a hospital employee via wheelchair.The patient was in a seated position when the seat and back support material began to fold/collapse due to the ferrous properties of the metal support frame as the wheelchair was pulled (attracted) to the magnet's bore.The magnet was intentionally quenched by one of the mri technologist out of concern for patient safety.It was reported the left side of the patient's body made contact with the bore.Per information verbally provided to the imris customer service engineer, x-rays of the patient were obtained and reported as negative (no specific anatomic area of interest was provided), minor brusing of patient was reported; however, no serious injury was reported to the mri technologist or others present when the event occurred.

• Brand Name: IMRI 3T S
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): IMRIS IMAGING, INC; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer (Section G): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: stacy kramer ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036338
• MDR Report Key: 23528797
• Report Number: 3013026005-2025-00004
• Device Sequence Number: 9065564
• Product Code: LNH
• UDI-Device Identifier: 00857534006059
• UDI-Public: (01)00857534006059(11)20160820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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
• Device Model Number: 116118-000
• 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: 10/14/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2016
• 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