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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HITACHI LTD. HITACHI MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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HITACHI LTD. HITACHI MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Noise, Audible (3273)
Patient Problems Headache (1880); Tinnitus (2103)
Event Date 05/05/2019
Event Type  Injury  
Event Description
My name is (b)(6), (b)(6) dept of public health dept of public health, food and drug branch - (b)(6).I received complaint from (b)(6) had an mri performed at (b)(6) advanced imaging, (b)(6) on (b)(6) 2019.Complainant is on (b)(6).Complainant stated since she had the mri, her ears have been ringing; experienced headaches, and her brain is throbbing.Complainant stated the hitachi mri machine was very noisy.Complainant believes the hitachi mri is archaic.Complainant stated the pt prior to her left because the mri was so noisy.Complainant stated the security guard informed her other pts come out of the mri room staggering.Complainant was referred to have the mri performed upon her by dr (b)(6).Since the incident, complainant has changed (b)(6) drs to dr (b)(6) occupational health services, (b)(6).Complainant had originally contacted the (b)(6) dept of consumer affairs medical board.According to the complainant, a (b)(6) dept of consumer affairs medical board employee informed her that (b)(6) advanced imaging, (b)(6) does not possess a current (b)(6) dept of consumer affairs medical board license.
 
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Brand Name
HITACHI MRI
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
HITACHI LTD.
MDR Report Key8662429
MDR Text Key147027079
Report NumberMW5087077
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
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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