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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS MAGNETIC ERSONANCE IMAGER (MRI); SYSTEM, NUCLEAR MAGNETIC RESONANCE
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GE MEDICAL SYSTEMS MAGNETIC ERSONANCE IMAGER (MRI); SYSTEM, NUCLEAR MAGNETIC RESONANCE Back to Search Results
Model Number SIGMA 1.5T
Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)
Patient Problems Hearing Impairment (1881); Tinnitus (2103)
Event Date 09/18/2019
Event Type  Injury  
Event Description
I underwent an mri exam of my right shoulder as requested by mt orthopedic surgeon.The mri technician did not advise me of the risk of hearing damage posed by these machines.The technician placed an ill-fitting set of ear muffs on me and did not verify proper fit.The ear muffs were loose fitting and did not completely cover both ears.I was not offered dual hearing protection (ear plugs and ear muffs) as recommended by various hospitals and clinics.I underwent a 25 minute mri scan subjected to dangerous noise levels.As a direct result of the mri scan, i have suffered serious and permanent hearing damage.I now suffer from tinnitus and hyperacusis which i did not have prior to the mri scan.This could easily have been prevented had the mri technician followed proper safety protocols.Fda safety report id # (b)(4).
 
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Brand Name
MAGNETIC ERSONANCE IMAGER (MRI)
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE
Manufacturer (Section D)
GE MEDICAL SYSTEMS
MDR Report Key9504543
MDR Text Key172616205
Report NumberMW5091794
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 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSIGMA 1.5T
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age48 YR
Patient Weight79
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