MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. GE OPTIMA CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 090-CE0001783

Device Problem Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2022

Event Type  malfunction  

Event Description

Ct scanner leaving artifact on images.Manufacturer notified.Engineers performed tube re-alignment.Images currently appear better.Fda safety report id # (b)(4).

• Brand Name: GE OPTIMA CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.
• MDR Report Key: 15690598
• MDR Text Key: 302773967
• Report Number: MW5112930
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 090-CE0001783
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male