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 05/22/2023

Event Type  malfunction  

Event Description

It was reported that during a craniotomy with intra-operative imaging planned, the mri magnet would not move due to continuous errors from the device's collision detection system.The errors prevented intended mri movement from the diagnostic room to the imaging position in the operating room, and intra-operative imaging was not possible prior to closure of the skull.Upon completion of the surgery, the surgeon removed the patient from the skull pins, dressed the wound and ordered post-operative mr imaging in the diagnostic room.It was reported that additional anesthesia was administered and approximately 45 minutes of delay was incurred in connection with the system errors.The patient was reported to be doing well after completion of the case and no additional surgical intervention was required based on post-operative imaging.

Manufacturer Narrative

An imris service engineer was on-site later the same day and identified a break in the pressure sensor array within the collision detection system was causing errors preventing magnet movement.The collision detection system functions to prevent mri movement in the event of a collision and was locking out mri movement as a safeguard; however, no collision had occurred in this event.System function was restored and the manufacturer has initiated internal corrective action to further investigate and address this issue.

Manufacturer Narrative

The root cause was traced 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.A break in the sensor array produced inadequate electrical continuity and produced a fault condition locking out mri magnet movement.The break likely occurred during standard third-party service.This event was reported due to the length of procedural delay under anesthesia reported by the end user.The procedure was reported to be successful and no patient injury occurred.

• 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: 17167194
• MDR Text Key: 318111696
• Report Number: 3010326005-2023-00005
• 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,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 05/22/2023
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 55 KG