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

Model Number 3T SKYRA

Device Problem Device Unsafe to Use in Environment (2918)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2019

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 294831233
• Report Number: 3010326005-2019-00033
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00857534006059
• UDI-Public: 00857534006059
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K133692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3T SKYRA
• Device Catalogue Number: 116118-000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1