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

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Smoking (1585); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

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

The site reported that while scanning a knee using the gem flex coil, the technologist noted smoke rising from the table.The technologist stopped the exam and removed the patient from the table.The technologist then used the pad from the table to extinguish the fire.No injuries were reported.The technologist found the table and pad were charred.Upon further investigation, service found the right side balun had burned.The coil used for this exam was examined and there was an area noted on the cable that was melted which indicates that the cable was looped and therefore cables were crossed.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.At the system level, the system error log was inspected for any indication that could have been a potential issue with the system.It was concluded that the system was performing as expected and within the system specifications.Visual inspection confirmed cable looping between the coil and the interface box led to the table cable track balun damage resulting in the tabletop burn.The root cause of the incident was that the site did not follow proper coil setup or cable routing procedures as indicated in the coil operator manual.Warnings in the instructions for use indicate that crossing or looping of cables can compromise patient safety.The mr operator has the final responsibility for the use and placement of the coil set-up and preparation of the patient, prior to starting the mr exam procedure.No further actions are planned by gehc.

• 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 (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 14790469
• MDR Text Key: 295042878
• Report Number: 2183553-2022-00009
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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