MAUDE Adverse Event Report: IMRIS IMAGING, INC IMRIS IMRI 3T V; System, nuclear magnetic resonance imaging

Model Number	120823-000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The magnet mover experienced a mechanical malfunction causing an unexpected downtime condition with a patient under anesthesia for more than one hour, leading to an extended procedural delay.Per the site, the patient remained stable, and no adverse events or unanticipated patient outcomes were identified.The procedure was completed, and the end user reported there was no serious injury or harm to the patient as a result of the issue.After the initial malfunction was corrected, a separate event rendered the mr scanner fully inoperable, causing more than one hour of unplanned downtime while the patient remained under anesthesia.The customer service engineer was contacted and resolved the issue.The procedure was completed, and the end user reported no serious injury or harm to the patient.
Additional Manufacturer Narrative
This event was reported due to the length of procedural delay under anesthesia reported by the end user.The end user reported there was no serious injury or harm to the patient.The manufacturer has initiated internal corrective action to further address this issue.

• Brand Name: IMRIS IMRI 3T V
• Common Device Name: System, nuclear magnetic resonance imaging
• 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: 24639914
• Report Number: 3010326005-2026-00002
• Device Sequence Number: 13279402
• Product Code: LNH
• UDI-Device Identifier: 00857534006745
• UDI-Public: (01)00857534006745(11)211026
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 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: 02/24/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: 16 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG