MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE MRI; SYSTEM, NUCLEAR MAGNETRIC RESONANCE IMAGING

Model Number SIGNA EXPLORER 1.5T

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/03/2019

Event Type  Injury  

Event Description

Patient had left shoulder mri.Patient sustained second degree burn to the right forearm.

• Brand Name: GE MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETRIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 8866106
• MDR Text Key: 153561394
• Report Number: MW5088815
• 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: 07/17/2019

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: No Information
• Device Model Number: SIGNA EXPLORER 1.5T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 100