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

Model Number	120823-000
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris customer service engineer assessed the device at the customer site and confirmed the pressure sensors were oversensitive.This produced inadequate electrical continuity and a fault condition locking out mri magnet movement.The root cause related to device design, specifically to requirements for serviceability and repeatable collision detection without producing a fault condition or error message.The integrated pressure activated collision detection system design was functioning as intended to prevent mri magnet movement where the system exhibits an underlying fault condition.This event was reported due to the length of procedural delay under anesthesia reported by the end user before magnet movement was enabled.The end user reported no patient injury occurred.The manufacturer has initiated internal corrective action to further address this issue.
Event or Problem Description
The customer reported that during a craniotomy with intra-operative imaging planned, the collision detection system was activated and would not let the user move the mri scanner.Multiple attempts to troubleshoot were made by the user before the mri scanner was functional again.The customer reported a delay to the procedure of over one hour and administration of additional anesthesia to cover the time during the delay.The craniotomy procedure was resumed after imaging was obtained, and the customer reported there was no serious injury or harm to the patient as a result of the issue.

• 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: 18333025
• Report Number: 3010326005-2023-00013
• Device Sequence Number: 6703215
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 11/15/2023
• Initial Report FDA Received Date: 12/14/2023
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 39 KG