MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696)

Event Date 08/03/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).There are no additional device identification numbers.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that following an mr exam of the left shoulder, it was discovered that the patient had a round, 2-3 inch burn on the lateral aspect of their right upper arm.The burn was evaluated at the site and diagnosed as a full thickness burn which resulted in a surgical procedure requiring debridement and a skin graft.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.Based on the test, configuration, and log information from the site, the incident appears to be the result of the coupling with intended high power radiofrequency (rf) energy.All data reviewed indicates that the system was operating normally and within performance specifications.The customer indicated the patient was properly padded and positioned for the exam.The information reviewed did not indicate there was any system malfunction that may have contributed to the incident.No further actions are planned at this time.

• Brand Name: SIGNA ARCHITECT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8944933
• MDR Text Key: 155970031
• Report Number: 2183553-2019-00020
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 83