FDA Adverse Event Malfunction Summary report: N

SIGNA ARTIST

MDR report key: 11705943 · Received April 22, 2021

Report

Report Number
11705943
Event Type
Malfunction
Date Received
April 22, 2021
Date of Event
March 19, 2021
Report Date
April 16, 2021
Manufacturer
GENERAL ELECTRIC COMPANY
Product Code
LNK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
605360 SIGNA ARTIST SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNK GENERAL ELECTRIC COMPANY SIGNA ARTIST

Patients

Seq Age Sex Outcome Treatment
1 25185 DA