• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Hearing Impairment (1881); Tinnitus (2103)
Event Date 07/08/2021
Event Type  Injury  
Manufacturer Narrative
Unique identifier: udi not required. 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
Following the completion of an mri scan of the abdomen, a patient reported that her hearing felt muffled. The patient, who was provided ear plugs and headphones, was seen in urgent care and diagnosed with tinnitus and prescribed steroids. The patient was monitored and after 10 days, the ringing in her ears persisted. The patient then underwent a hearing test and hearing loss was confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12283219
MDR Text Key265340579
Report Number2183553-2021-00008
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
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: 08/05/2021 Patient Sequence Number: 1
-
-