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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number MR750W
Device Problem Electromagnetic Interference (1194)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  No Answer Provided  
Event Description
While bringing patient into the mri scan room for her outpatient magnetic resonance angiography (mra) brain, the patient's glasses were pulled off of her face and flew into the scanner bore. The glasses broke in half when they struck the inside of the bore. No injury to the patient.
 
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Brand NameDISCOVERY MR750W 3.0T
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd
waukesha WI 53188
MDR Report Key9543051
MDR Text Key173466544
Report Number9543051
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberMR750W
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2019
Event Location Hospital
Date Report to Manufacturer01/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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