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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC (GE) MRI MACHINE

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GENERAL ELECTRIC (GE) MRI MACHINE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Alteration In Body Temperature (2682)
Event Date 02/01/2018
Event Type  Injury  
Event Description
Reporter states that he has multiple metal implants and rods/screws in his body attached to his skeleton, and that he has had a series of mri's without any issues. He stated that when he went for his mri yesterday ((b)(6) 2018), while in the machine, he felt as if he was being cooked from inside out. According to reporter, the heat was such that he had to be pulled out of the machine few minutes upon completion. Reporter says the technician on duty told him the reaction he was having was due to all the metals in his body. According to reporter, he had never felt this way before and found it to be a very strange experience. Reporter says he would like to know what actually happened and the after effect of such reaction to his body. For as reporter explains, the hospital staff never gave him any explanation.
 
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Brand NameMRI MACHINE
Type of DeviceMRI MACHINE
Manufacturer (Section D)
GENERAL ELECTRIC (GE)
MDR Report Key7240945
MDR Text Key99103281
Report NumberMW5075048
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 Patient
Type of Report Initial
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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

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