MAUDE Adverse Event Report: GENERAL ELECTRIC COMPANY SIGNA ARTIST; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SIGNA ARTIST

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

This is one of two recent events where right and left (laterality) were reversed on the coronal mri images performed on a ge.The neurosurgeon has been in contact with radiology/imaging leadership about these laterality issues.The cause is evidently related to technologist's error in inputting data after a recent ge software upgrade, but the software allows this to happen with patient orientation changes unknown to the technologist performing the study.This type of error obviously has significant risk of wrong sided surgery if the error is not caught.Even when the error is caught, there remains significant exposure for a patient error later because these images are included in the patient's electronic medical record and could be viewed by a surgeon in the future, who is unaware that this laterality issue impacted the views that she/he is seeing.Manufacturer response for ge 26 & 28.O platform, (brand not provided) (per site reporter): ge is aware.Our mr imaging leaders have been in communication with our physician and technologist staff in regard to this issue across all our campuses and have asked that a gadolinium marker be placed on the left temple for all brain mri cases.Our mr imaging leaders are currently reviewing marker placement with staff and will be auditing all brain mri cases to ensure compliance.In addition, we have been in communication with ge on a software patch.The current timeline ¿per ge¿ for completion is december 2021.This timeline is unacceptable to the mri leadership team (this is a huge safety concern).Discussions as it relates to this issue are ongoing as we look for a permanent solution from ge.

• Brand Name: SIGNA ARTIST
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC COMPANY; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 11705943
• MDR Text Key: 248353001
• Report Number: 11705943
• Device Sequence Number: 1
• Product Code: LNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGNA ARTIST
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 84