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

Model Number	NL4000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon investigation, an issue was found while preparing to operate on a cranial brain injury patient when the team noticed that patient could not be scanned because of the error message, that the detector data conversion board is faulty.To resolve the problem, they replaced the component board and cable.System was tested to operate functionally, passed calibration and qa scans.
Event or Problem Description
The customer reported, according to the error message, that the detector data conversion board is faulty and cannot be scanned.

• Brand Name: NL4000
• Common Device Name: 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: 18111766
• Report Number: 3004938766-2023-00023
• Device Sequence Number: 7863296
• Product Code: JAK
• UDI-Device Identifier: 10815411020267
• UDI-Public: 011081541102026711190801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Notification
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown