MAUDE Adverse Event Report: GENERAL ELECTRIC CO. ARCHITECT 3T MRI; SYSTEM, NUCLEAR MAGNETIC RESONNANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Date 04/22/2019

Event Type  Injury  

Event Description

Radiofrequency burn during mri exam.

• Brand Name: ARCHITECT 3T MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONNANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC CO.
• MDR Report Key: 8636315
• MDR Text Key: 146100483
• Report Number: MW5086848
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 200