MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE LIGHTSPEED VT SCAN INSTALLED IN 2006; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Signal Artifact/Noise (1036); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  Injury  

Event Description

Artifact was detected on 16 out of 99 head cts completed in ct2 from 8/20/2021 to 8/26/2021 biotronics and ge rep was involved and responded immediately on (b)(6) 2021, there was an artifact identified by one of our radiologists that resembled an ischemic event or general white matter changes on brain cts.This artifact was identified when subsequent imaging (either ct on another unit or mri) was completed and was grossly normal when compared to the scan done on ct2.As soon as this artifact was identified, the scanner was shut down and service (ge and biotronics) was called and responded in a timely manner.Service identified that the artifact was caused by air bubbles in the cooling oil of the x-ray tube.They were able to reproduce the artifact by tilting the scanner gantry to a 15 to 20 degree angle while performing an axial scan.Once the cause of the artifact was identified, ge field service engineers evacuated the air from the system and the unit was returned to service.In order to identify the start date of the artifact, groups of head scans were reviewed going back one week at a time, until the artifact was not able to be seen three days in a row.This date was determined to be (b)(6) 2021.Out of this group of approximately 400 scans, 46 were identified as having the artifact.Each of these 46 exams were reviewed by radiologist and quality team and it was determined to either reimburse scan, subsequent scans and/or hospitalizations, provide additional scans for clarification, or proceed with normal charges.In order to identify artifact in the future, it was determined to perform angled scans along with straight scans on daily qc phantom and document whether artifact was present or not.Fda safety report id# (b)(4).

• Brand Name: GE LIGHTSPEED VT SCAN INSTALLED IN 2006
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 12665419
• MDR Text Key: 277871998
• Report Number: MW5104783
• Device Sequence Number: 1
• Product Code: JAK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other