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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC CO. GE 450 W MRI SCANNER 1.5 TESLA MAGNET UNK SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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GENERAL ELECTRIC CO. GE 450 W MRI SCANNER 1.5 TESLA MAGNET UNK SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burning Sensation (2146)
Event Date 10/13/2018
Event Type  No Answer Provided  
Event Description
Mri technologist, (b)(6), had an outpatient on saturday (b)(6) 2018 for 3 mris, a brain with and without, a thoracic with and without, and a cervical with and without. (b)(6) said the pt felt a warming / burning sensation on the top of her head during her mri exam. The technologist checked the pt's head and she seemed fine and the scan room fan was turned all the way up. The pt was unable to finish all 3 mris ordered, which was a brain, cervical thoracic all with and without contrast. She was only able to do the brain without and thoracic without. The thoracic without was done first, followed by the brain. She returned monday (b)(6) 2018 to finish her exams. When i observed her on (b)(6) 2018 before her mri she had a small red area, the size of half of a pencil eraser top on her scalp. I asked the radiologist, dr (b)(6). If it was okay to do her mri that day. He said yes and to check on the pt after every sequence and to stop immediately if she felt any burn/warming sensation. The pt had her mri on (b)(6) 2018 with no complaints. She had her brain with contrast, thoracic with contrast and cspine with and without contrast on (b)(6) 2018. It was confirmed that the pt had no metal or previous surgery in that area, pt's hair was not wet and sar levels were checked and confirmed that the pt was scanned on normal mode. The second time she came, she was done on our siemens mri instead of the ge mri scanner she was originally on.
 
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Brand NameGE 450 W MRI SCANNER 1.5 TESLA MAGNET UNK
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GENERAL ELECTRIC CO.
MDR Report Key7973490
MDR Text Key124500527
Report NumberMW5080598
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
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 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
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