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

Model Number	NL4100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an issue with a faulty component due to that the patient was transferred to an alternate system for rescanning, which resulted in a treatment delay.
Additional Manufacturer Narrative
There was a problem with a faulty component due to the patient was partially scanned before the scanner malfunctioned, requiring a transfer to another system for rescanning, which delayed their treatment.The corrective measure is to replace it with a new system with appropriate software upgrades.There was no harm to the patient or user.Any additional information received on this incident will be reported in a follow-up mdr.

• 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: 22931149
• Report Number: 3004938766-2025-00024
• Device Sequence Number: 21421193
• Product Code: JAK
• UDI-Device Identifier: 10815411020533
• UDI-Public: (01)10815411020533(11)250702
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: 08/01/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown