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

Model Number 120823-000

Device Problems Mechanical Jam (2983); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 330971919
• Report Number: 3010326005-2023-00013
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00857534006745
• UDI-Public: (01)00857534006745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120823-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 39 KG