MAUDE Adverse Event Report: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 08/04/2021

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 a patient sustained a 3rd degree burn to the medial aspect of the right ankle during an mr examination of the pelvis.The patient underwent a debridement of the burn.The patient was scanned with a damaged torso array coil and no padding was used to prevent patient contact with the magnet bore or body loops.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The system was evaluated and no failures were noted that would contribute to a patient warming event.According to the information available in the patient warming questionnaire provided by the customer, no pads were used to prevent contact with the magnet bore or to prevent the creation of body loops (hand to thigh, thigh to thigh, etc.) per ge recommendation.In addition, the coil cable was positioned without pads, which are to prevent the creation of loops and contact with the patients skin.Based on this information, the likely primary root cause of the incident is â incorrect use of padding the operator documentation describes the appropriate safety measures for padding patients for mr exams.In addition, section conductive material heating states: before scanning, warn patients with permanent eyeliner or other metallic ink tattoos about the risk of skin irritation and instruct them to get prompt medical attention if they experience severe discomfort following an mr exam.The mr operator has the final responsibility for the use and placement of non-conductive mr compatible padding and preparation of the patient, prior to starting the mr exam procedure.No further actions are planned by gehc.

• Brand Name: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 12415081
• MDR Text Key: 269609329
• Report Number: 2183553-2021-00009
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K121676
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 80