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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC GENERAL ELECTRIC DISCOVERY 3T MRI

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GENERAL ELECTRIC GENERAL ELECTRIC DISCOVERY 3T MRI Back to Search Results
Model Number DISCOVERY 3T
Device Problems Fire (1245); Smoking (1585); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2017
Event Type  Injury  
Event Description
During an mri examination, the mri unit stopped working, when the technologist entered the scan room to see what was wrong, they smelled smoke and saw smoke and possible flames in a closet behind the scanner that houses the pass through filter from the equipment room into the scan room. The technologist immediately removed the pt from the room (without incident) and instructed others in the area there was a fire, to pull the alarm and evacuate all pts. The technologist then went back with an mri safe fire extinguisher and extinguished the small fire. There were no injuries reported. Fire department arrived and verified the fire had been fully extinguished.
 
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Brand NameGENERAL ELECTRIC DISCOVERY 3T MRI
Type of DeviceMRI
Manufacturer (Section D)
GENERAL ELECTRIC
waukeshaw WI
MDR Report Key6653084
MDR Text Key77948227
Report NumberMW5070499
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDISCOVERY 3T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/19/2017 Patient Sequence Number: 1
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