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

Model Number	3T SKYRA
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is a known risk that the introduction of ferrous objects into the mr suite can cause damage or injury if they are drawn towards the magnet.All suites are equipped with safety labels informing users and visitors of the hazards intrinsic to the mr environment.The underlying cause of the incident was user error.The service technician failed to verify that the magnet was deployed and that the server on the equipment rack was located in an mr unsafe zone.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 siemens service technician was working on a software upgrade in the equipment room positioned adjacent to the magnet in the diagnostic room.As the technician was attempting to remove and replace a computer server from the equipment rack, the server attracted to the magnet.The technician's left hand was caught between the server and the magnet.The technician was able to extricate his left hand from between the magnet and the equipment, and damage to the technician's middle finger occurred during this process.The technician was treated in the emergency room onsite.The magnet was ramped down to retrieve the server from the side of the magnet.

• 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: 13516141
• Report Number: 3010326005-2017-00002
• Device Sequence Number: 4474310
• Product Code: LNH
• UDI-Device Identifier: 00857534006035
• UDI-Public: 00857534006035
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/04/2017
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2014
• 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: Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 73 KG