MAUDE Adverse Event Report: NEUROLOGICA CORP NL5000; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL5000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The heating tube was preventing the scanner from scanning.The issue was a defective monoblock heat exchanger temperature sensor.The corrective action for the ticket was to replace the temperature sensor.There has been no harm to the patient or user.No additional patient information has been received; if further information is found, a follow-up mdr will be submitted.
Event or Problem Description
The patient procedure was delayed because the tube was heating and preventing the scan.

• Brand Name: NL5000
• 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: 21360256
• Report Number: 3004938766-2025-00005
• Device Sequence Number: 15571889
• Product Code: JAK
• UDI-Device Identifier: 10815411020663
• UDI-Public: (01)10815411020663(11)240102
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K202526
• 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: Notification,Repair
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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: NL5000
• Device Catalogue Number: 0-NL5000-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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