MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS 3T SKYRA SYSTEM; MAGNETIC RESONANCE IMAGING DEVICE

Model Number	SKYRA 3T
Medical Device Problem Codes	Unintended Collision (1429); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While moving the magnet from the operating room to the diagnostic room on (b)(6) 2020, a staff member brought in an mr-unsafe linen cart and it was drawn into the magnet.The magnet was physically damaged by the linen cart, breaking the front funnel cover, the collision detection ring, and some electrical connections inside the body coil.There was no patient involvement and the user did not sustain any injury.
Additional Manufacturer Narrative
The root cause of the incident was traced to user error.This was user error by this particular staff member and was not a malfunction of the device.The front funnel cover, collision detection ring, and electrical connections to the body coil were damaged by the linen cart and were replaced.Afterwards, the system was tested to verify proper function.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.

• Brand Name: IMRIS 3T SKYRA SYSTEM
• Common Device Name: MAGNETIC RESONANCE IMAGING DEVICE
• 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: 13446585
• Report Number: 3010326005-2020-00013
• Device Sequence Number: 14529186
• Product Code: LNH
• UDI-Device Identifier: 00857534006059
• UDI-Public: 00857534006059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Remedial Action: Repair,Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: Health Professional
• Device Model Number: SKYRA 3T
• Device Catalogue Number: 116118-000
• 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: 06/18/2020
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• 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