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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC MR SIGNA VOYAGER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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GE HEALTHCARE MANUFACTURING LLC MR SIGNA VOYAGER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Brain Injury (2219)
Event Date 11/19/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 in (b)(6) at the (b)(6) i was in (b)(6). The persons was in a hospital the (b)(6). I was in the emergency room with a persons named (b)(6). The persons (b)(6) conducted a rad cat mri brain scan using general electric equipment that caused severe brain damage and images of the skull. There was an adult male black hair college student on staff as well. Radiation of the brain at general electric, images of the skull, cat rad mri scans on campus at (b)(6). Inside of the (b)(6) hospital. I was fed normal food delivery fast food. They were in the emergency room here one time, and were given imaging of the brain and skull. Sample, homeless student from dormitory. Fda safety report id # (b)(4).
 
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Brand NameMR SIGNA VOYAGER
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE HEALTHCARE MANUFACTURING LLC
MDR Report Key13010984
MDR Text Key282353283
Report NumberMW5106041
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 12/09/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date10/20/2020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
HERBAL REMEDIES
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