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

Model Number SKYRA

Device Problems Unintended Collision (1429); Device Handling Problem (3265)

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

Event Date 09/09/2019

Event Type  malfunction  

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 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
• 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: 13424965
• MDR Text Key: 287274245
• Report Number: 3010326005-2019-00027
• 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: Other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/09/2019

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: SKYRA
• Device Catalogue Number: 116118-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• 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