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

Model Number LIGHTSPEED

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  malfunction  

Event Description

Patient was prepped and prepared for ct scan.After scanning, the technologist hit buttons to scan the image and the machine went down.Patient was moved to another machine and test completed.Radiology engineering contacted and discovered host computer issue.Replacement part ordered, installed and software reloaded.

• Brand Name: LIGHTSPEED VCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HEALTHCARE; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 17441923
• MDR Text Key: 320214230
• Report Number: 17441923
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/13/2023

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: Health Professional
• Device Model Number: LIGHTSPEED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Female
• Patient Race: White