MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE LIGHTSPEED VCT 64 SLICE CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number GE LIGHTSPEED VCT 64 SLICE

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Ge light speed 64 slice scanner has table issues, table stops during scans due to micro switch in table breaking or bending while scanning.Reboot works sometimes.

• Brand Name: GE LIGHTSPEED VCT 64 SLICE CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 12083379
• MDR Text Key: 258909430
• Report Number: 12083379
• 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: 06/23/2021,06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GE LIGHTSPEED VCT 64 SLICE
• 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: 06/23/2021
• Date Report to Manufacturer: 06/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1