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

Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

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

It was reported that while preparing the room for an mr exam and prior to patient entry, the technologist noticed a small section of the table appeared to be burned.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices were functional when checked by the gehc field engineer.The third-party vendor found no deficiencies in the gems flex coil.The root cause of the incident was misuse by setting up the coil in a way that does not follow cable routing safety warnings as described in the operator documentation.The operator manual and warnings provide that crossing or looping of cables may result in burns to the patient.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
• MDR Report Key: 12162397
• MDR Text Key: 263413840
• Report Number: 2183553-2021-00007
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K143345
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1