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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tinnitus (2103); Partial Hearing Loss (4472)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
Unique identifier: (b)(4). There are no additional device identification numbers. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that a patient experienced hearing loss that progressed to tinnitus following a brain mri/mra exam. The patient was supplied with the standard facility ear plugs, but stated that the system was still loud. The patient squeezed the alert bulb and at that point, the technologists placed additional pads between his ears and the inside of the head coil. The patient elected to complete the exam noting that the sound was decreased with the additional padding in place. The patient's hearing loss has almost completely subsided, but the tinnitus remains. The patient was fitted for a tinnitus ear bud but has elected not to wear the device.
 
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Brand NameDISCOVERY MR750W 3.0T
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer (Section G)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
andy koch
3200 n. grandview blvd.
waukesha, WI 53188
MDR Report Key11806717
MDR Text Key250613501
Report Number2183553-2021-00006
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/11/2021 Patient Sequence Number: 1
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