MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS NEURO-III SV SYSTEM WITH 3T VERIO MAGNET; MRI MAGNET

Model Number N/A

Device Problems Device Unsafe to Use in Environment (2918); Environmental Compatibility Problem (2929); Human-Device Interface Problem (2949); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

The underlying cause of the incident is user error.The service engineer was in error when he attempted to remove the mr-unsafe ifoss controller box from the suite while the magnet was deployed.

Event Description

The service engineer was removing the ifoss controller box.Once the hardware was removed, the controller was attracted towards the magnet, was pulled downwards, and stuck to the side of the magnet.No injuries were reported.

• Brand Name: IMRIS NEURO-III SV SYSTEM WITH 3T VERIO MAGNET
• Type of Device: MRI MAGNET
• 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: todd sperling ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 7355821
• MDR Text Key: 103277855
• Report Number: 3010326005-2018-00031
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/19/2018

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
• Device Operator: Service Personnel
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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