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

Model Number 7.1.14

Device Problem Image Orientation Incorrect (1305)

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

Event Date 01/11/2021

Event Type  malfunction  

Event Description

Last month, the neurosurgery quality assurance surgeon alerted the mri department to a right/left laterality reversal on the mri images performed for the patient listed in this medsun report.It was caught because a known tumor was presenting on the opposite side in comparison to prior mri exams performed at an outside community hospital.An investigation into the cause showed the particular system software platform the patient was imaged on has the location of the patient orientation selection button extremely close to the save series button.This is different in comparison to two other ge mri platforms at the main campus.The only notification to the technologist of this happening would be a slight change in a small animation on the scanner console which is easily overlooked.We believe the minor change in the position of the patient orientation button is the root cause for the mislabeled images.That radiologist that dictated the exam was paged and has entered an addendum to the report regarding the right/left reversal.The following was initiated by radiologist member of the mri qa team: to prevent future mislabeled exams: made all the staff (managers and technical staff) aware of the issue.Urgent email with slides.Called each ge scanner and spoke with the scanning technologists.Scheduled/had an emergency meeting with the vendor this afternoon.Sent screen shots to the vender as well.We are also inquiring about generating a report for a specific dicom tag to see if there are other mislabeled cases which have not been identified.Ge representatives were alerted to this last month (soon after the event occurred).

Event Description

Last month, the neurosurgery quality assurance surgeon alerted the mri department to a right/left laterality reversal on the mri images performed for the patient listed in this medsun report.It was caught because a known tumor was presenting on the opposite side in comparison to prior mri exams performed at an outside community hospital.An investigation into the cause showed the particular system software platform the patient was imaged on has the location of the patient orientation selection button extremely close to the save series button.This is different in comparison to two other ge mri platforms at the main campus.The only notification to the technologist of this happening would be a slight change in a small animation on the scanner console which is easily overlooked.We believe the minor change in the position of the patient orientation button is the root cause for the mislabeled images.That radiologist that dictated the exam was paged and has entered an addendum to the report regarding the right/left reversal.The following was initiated by radiologist member of the mri qa team: to prevent future mislabeled exams: made all the staff (managers and technical staff) aware of the issue.Urgent email with slides.Called each ge scanner and spoke with the scanning technologists.Scheduled/had an emergency meeting with the vendor this afternoon.Sent screen shots to the vender as well.We are also inquiring about generating a report for a specific dicom tag to see if there are other mislabeled cases which have not been identified.Ge representatives were alerted to this last month (soon after the event occurred).

• Brand Name: SIGNA ARTIST
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC COMPANY; 12625 high bluff dr; suite 205; san diego CA 92130
• MDR Report Key: 11301046
• MDR Text Key: 230953954
• Report Number: 11301046
• 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,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7.1.14
• Device Catalogue Number: 617726ERMR
• 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: 01/21/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA