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

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).

• Brand Name: MR SIGNA VOYAGER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 13010984
• MDR Text Key: 282353283
• Report Number: MW5106041
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/20/2020
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: HERBAL REMEDIES
• Patient Outcome(s): Hospitalization; Life Threatening; Disability; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White