MAUDE Adverse Event Report: GE HEALTHCARE LIGHTSPEED PRO 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Computer Operating System Problem (2898); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Event Description

During a soft tissue biopsy procedure, the ct scanner stopped working.Firmware error noted and rebooting issues.New scanner used.No harm to patient.

• Brand Name: LIGHTSPEED PRO 16
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd; w-450; waukesha WI 53188
• MDR Report Key: 8342931
• MDR Text Key: 136272370
• Report Number: 8342931
• 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: 02/11/2019

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 119