MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC. GE SIGNA HDXT 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/18/2022

Event Type  Injury  

Event Description

Patient reports upper body burns on his neck, chest, back, and forehead after a cervical spine mri.

• Brand Name: GE SIGNA HDXT 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC.
• MDR Report Key: 15958926
• MDR Text Key: 305274385
• Report Number: MW5113718
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White