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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI MACHINE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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MRI MACHINE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Device Unsafe to Use in Environment (2918)
Patient Problems Erythema (1840); Alteration In Body Temperature (2682)
Event Date 04/10/2018
Event Type  Injury  
Event Description
I went to (b)(6), at a clinic for a chest mri. When i stepped into the room of the exam, i already perceived the room temperature to be elevated. During the exam, i felt that the temperature reached extremely high levels. I pushed the emergency button and i informed the technician that i was feeling extremely hot. The likelihood of damage -- i later learnt from the scientific literature -- is correlated to the duration of exposure to extreme temperatures. The exam was not stopped, however, in fact, it continued for quite some time (overall, the exam lasted about one hour, possibly more) and the heat i felt was extreme. Since the exam, i have been experiencing episodes during which i feel very hot and i become red in the neck, face, ears and hands. I have pictures. These episodes last from a few hours to several hours and occur daily or every couple of days. More than three months have now passed since the day of the exam and these episodes of heat and redness (which i never had before the exam) keep occurring.
 
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Brand NameMRI MACHINE
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key7697792
MDR Text Key114502201
Report NumberMW5078469
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
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