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

Device Problem Use of Device Problem (1670)

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

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).There are no additional device identification numbers.The investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices, including the redundant rf power monitors, were functional when checked by the gehc field engineer.The root cause of the injury was determined to be inadequate patient padding for the mri procedure with a secondary root cause of inadequate patient screening.The operator documentation describes the appropriate safety measures for padding patients for mr exams.In addition, section a 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.

Event Description

The customer reported that a patient underwent an mri of the spine, knee and pelvis.At the end of the exam, the patient mentioned to the technologist that their arm felt hot.The technologist examined the patient's arm and at the time, did not observe any areas of redness.The patient was then seen by their physician who stated that the patient had a burn which could have been received from the mri system.The customer was notified approximately three weeks after the event that the patient sustained a deep full- thickness burn to the back of the arm.The area of concern was a deep wound treated by packing the area with gauze and solugel.The burn/wound has been improving.The wound has scarred over and is currently about one inch wide.The patient has extensive "older" tattoos.Pads had been placed between the patient's legs, however pads were not provided against the sides of the bore or between the hand/arm and leg, per ge recommendation.

• Brand Name: SIGNA PIONEER
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jason kelly ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 11406443
• MDR Text Key: 234511684
• Report Number: 2183553-2021-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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: 25 YR
• Patient Weight: 82