MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS IMRI 3T SKYRA SYSTEM; MRI MAGNET

Model Number 3T SKYRA

Device Problem Electromagnetic Interference (1194)

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

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

There is a known risk that the introduction of ferrous objects into the mr suite can cause damage or injury if objects are drawn towards the magnet.All suites are equipped with safety labels informing users and visitors of the hazards intrinsic to the mr environment which must be followed.The underlying cause of the incident was related to user error.The hospital staff failed to verify that the magnet was deployed upon carrying the unsafe shims into the magnetic field.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.

Event Description

On (b)(6) 2017, a hospital staff picked up a box of magnet shims in the hospital's equipment room without knowing what was inside.The staff brought the box through the magnetic field in the operating room and the box fell out of the staff's hand.As a result, the shims flew into the bore of the magnet causing a superficial damage to the bore.There was no patient injury reported due to the event.

• Brand Name: IMRIS IMRI 3T SKYRA SYSTEM
• Type of Device: MRI MAGNET
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13425258
• MDR Text Key: 284891234
• Report Number: 3010326005-2018-00002
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00857534006035
• UDI-Public: 00857534006035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/15/2017

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 Operator: Other
• Device Model Number: 3T SKYRA
• Device Catalogue Number: 116053-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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