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

Model Number	3T SKYRA
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, an imris program manager was inside the newly constructed and installed or suite with two photographers.A ferrous object was drawn from the hand of one of the photographers into the bore of the magnet.There was no patient invovlement or user injury reported due to the event.
Additional Manufacturer Narrative
The company representative and photography team were previously trained on mr safety.The object drawn into the magnet bore was a small metal clip.Unintended, non-user error caused the event; no device malfunction, nor patient or user involvement occurred.The ferrous object was safely removed from the magnet bore and 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 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: 13425087
• Report Number: 3010326005-2019-00033
• Device Sequence Number: 3953453
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 3T SKYRA
• Device Catalogue Number: 116118-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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