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	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A malfunction with the scanner causing the re-scan and delay in the patient procedure.
Additional Manufacturer Narrative
A malfunction with the scanner causing the re-scan and delay in the patient procedure.We've implemented corrective measures to mitigate risks and prevent errors.Daily calibration and quality assurance testing on the system were completed without any issues.No patient harm or other issues were reported.No additional patient information has been received; if further information has been found follow-up mdr will be submitted.

• 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: 21607429
• Report Number: 3004938766-2025-00012
• Device Sequence Number: 9217284
• Product Code: JAK
• UDI-Device Identifier: 10815411020663
• UDI-Public: (01)10815411020663(11)230512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/14/2025

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: 02/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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