MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 3.0T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Burn(s) (1757); Swelling (2091)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi not required.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 during their mr exam, a patient developed a burn and blister on the right calf area.The patient made the technologist aware and the exam was stopped immediately and the area was rinsed with cool tap water for 30 minutes, disinfected and bandaged.Two days later when changing the dressing on the calf area, a burn and blister were also noted on the patient's heel.Both areas are being treated with multiple dressing changes over time as they heal and in every dressing change, cleaning the wound and removing dead skin tissue.The customer stated that all ge recommended rf padding was used for the exam.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.Based on the information provided, the root cause of the incident is warming despite sar within limits.No systemic issues were identified.The system was operating normally when checked by the gehc field engineer.The customer indicated the patient was properly padded for the exam.The information reviewed did not indicate that there was any system malfunction that may have contributed to the incident.No further actions are planned at this time.

• Brand Name: GE 3.0T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10333754
• MDR Text Key: 200761905
• Report Number: 2183553-2020-00009
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 65