MAUDE Adverse Event Report: NEUROLOGICA CORP NL4100; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL4100
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The loss of connection and blank scanner screens occurred due issue with the reconstruction computer hardware.The corrective measure was performed, and connection to the scanner was established by restarting it.Ran a qa test.All fields passed.No harm to patient or users.
Event or Problem Description
While operating the system, the user observed that the scanner's status indicator was not displaying the expected blue light.Shortly afterward, the scanner screens went blank and the system lost connection to the workstation causing delay in the treatment.

• Brand Name: NL4100
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORP; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORP; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923
• MDR Report Key: 23659521
• Report Number: 3004938766-2025-00030
• Device Sequence Number: 9962145
• Product Code: JAK
• UDI-Device Identifier: 10815411020533
• UDI-Public: (01)10815411020533(11)241227
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K213649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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 Model Number: NL4100
• Device Catalogue Number: 0-NL4100-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2025
• 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