MAUDE Adverse Event Report: NEUROLOGICA CORPORATION NL4000; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number NL4000

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation completed by our service team, there was no issue with the scanner.We would retrain the customer that if the daily calibration displays a warning, they should not scan the patient.

Event Description

The customer reported, on (b)(6) 2023, when the department of thoracic surgery was using the nl4000 to perform an ablation procedure of lung lesions or lung tissue for patient, the device experienced a malfunction of large artifacts or non-imaging of the scanning image, and was unable to play the role of ct imaging puncture guidance, which resulted in the inability to continue to complete the procedure.They had to immediately stop using the device, quickly use other equipment in the same operating room to complete the puncture and needle withdrawal and other follow-up work, calm the patient, and notify the equipment department for repair.

• Brand Name: NL4000
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923
• MDR Report Key: 18512395
• MDR Text Key: 333505708
• Report Number: 3004938766-2024-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NL4000
• Device Catalogue Number: 0-NL4000-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1