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U.S. Department of Health and Human Services

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

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IMRIS - DEERFIELD IMAGING, INC. IMRIS NEURO-III SV SYSTEM WITH 3T VERIO MAGNET MRI MAGNET Back to Search Results
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.
 
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Brand NameIMRIS NEURO-III SV SYSTEM WITH 3T VERIO MAGNET
Type of DeviceMRI 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 Key7355821
MDR Text Key103277855
Report Number3010326005-2018-00031
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Service Personnel
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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