MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC LIGHTSPEED VCT; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPG01

Device Problem Image Display Error/Artifact (1304)

Patient Problem Head Injury (1879)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: (b)(6).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.

Event Description

It was reported that four patients were hospitalized based on artifact that was determined to be a false positive.There was no injury.

Manufacturer Narrative

The air in the tube oil was purged as described in the service manual to repair the system.The investigation determined that the customer received a pink pop-up attention window that stated "the beam quality check has detected a problem.Image quality may be affected.Scanning will not be disabled.Call ge service today to schedule service to correct the problem.Press "ok" to proceed at the risk of image artifacts.쳌 the customer called ge for service 11 days later.

• Brand Name: LIGHTSPEED VCT
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd; waukesha WI 53188
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 13232426
• MDR Text Key: 288989045
• Report Number: 2126677-2022-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSPG01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male