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

Model Number	116118-000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation identified the error observed by the end user may relate to an error in software or configuration of the magnet mover system that drives motorized mr movement.This software component is not connected to any hospital or outside networks nor user accessible.System safety interlocks functioned as intended to lock out / prevent mri magnet movement and prevent intra-operative sliding doors from opening between diagnostic room and operating room if system status or location was not within specified limits.Further investigation is ongoing and a followup report will be submitted.
Event or Problem Description
During pmcf survey collection the customer identified an earlier event where the mri scanner was not able to be moved from the diagnostic room to the operating room to obtain intra-operative diagnostic images.The magnet mover produced an error message and disallowed linear movement into the operating room.The patient was transferred to another stationary mr scanner at the radiology department while still under anesthesia.The customer reported the procedure could be completed although with significant delay greater than 60 minutes while the patient was under anesthesia.
Additional Manufacturer Narrative
Imris field service engineer reset the encoder for the magnet mover rotational motor's position to zero at the home position, which was confirmed to resolve the interlock, and the software upgrade was then re-installed without further issue.The system's interlocks specify rotational position must be within a fraction of a degree off of zero; it is likely the rotational position drifted outside of this specification after a previous software upgrade and system testing was completed.The event was reported due to the length of procedural delay reported, no adverse impact on the patient was reported by the end user.No similar complaints of this nature have been received.Manufacturer training and the operator manual instruct for customer-performed qa checks prior to system use in a case to mitigate this type of event occurrence.

• Brand Name: IMRIS IMRI 3T S
• Common Device Name: MAGNETIC RESONANCE IMAGING
• 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
• MDR Report Key: 19367856
• Report Number: 3010326005-2024-00004
• Device Sequence Number: 7703055
• Product Code: LNH
• UDI-Device Identifier: 00857534006059
• UDI-Public: (01)00857534006059
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 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: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2018
• 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