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

Model Number	3T SKYRA
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010326005-2018-00002
• Device Sequence Number: 5354011
• Product Code: LNH
• UDI-Device Identifier: 00857534006035
• UDI-Public: 00857534006035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133692
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 3T SKYRA
• Device Catalogue Number: 116053-000
• 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: 12/15/2017
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2017
• 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
• Patient Sex: Unknown