MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC LIGHTSPEED PRO 100; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Device Inoperable (1663); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2016

Event Type  malfunction  

Event Description

The ct scanner experienced an irreparable failure during a biopsy procedure for evaluation of a high risk left lung, lower lobe nodule close to pulmonary arteries and veins.After the needle was successfully placed into the nodule, initial passes to obtain cytology specimens were successful.However, with the needle in the lung, the scanner was no longer able to move the table or produce additional images due to a hardware failure.A ge technician and the ct technologists were unsuccessful in restarting the scanner.The interventional radiologist did not feel it was safe to continue and obtain additional aspirates and terminated the procedure.The patient experienced no complications during the procedure and was discharged home 3 hours after the procedure.The diagnostic material obtained was sufficient for analysis.The pathology and molecular testing results were confirmed.The patient's clinical course was not affected by this event.The staff expressed concern about the reliability of the scanner given its age.The scanner was originally installed over 13 years ago.The unit received its last preventive maintenance (pm) a few months ago.It is currently up to date with all manufacturer's scheduled pm's.

• Brand Name: LIGHTSPEED PRO 100
• 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: 6116581
• MDR Text Key: 60461778
• Report Number: 6116581
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2016,10/31/2016

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
• Other Device ID Number: GE ASSET # 617724CT04
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2016
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 53 YR