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

Model Number	SKYRA
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	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no device malfunction.A trained cleaning personnel failed to follow instructions and inadvertently brought a mr-unsafe trolley into the or suite while the magnet was deployed.The trolley was drawn into the magnet and caused damage to the magnet bore.The damaged magnet cover and collision detection ring were replaced and the mr 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.
Event or Problem Description
On (b)(6) 2019, it was reported that a cleaning personnel was in the magnetic resonance suite while the magnet was deployed.An mr-unsafe trolley was drawn into the magnet, damaging the funnel cover and collision detection ring.There was no patient involvement and the user did not sustain any injury.

• Brand Name: IMRIS IMRI 3T SKYRA SYSTEM
• Common Device Name: MAGNETIC RESONANCE IMAGING SYSTEM,
• 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: 13424965
• Report Number: 3010326005-2019-00027
• Device Sequence Number: 20082104
• Product Code: LNH
• UDI-Device Identifier: 00857534006059
• UDI-Public: 00857534006059
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: SKYRA
• 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: 09/09/2019
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2016
• 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