MAUDE Adverse Event Report: NEUROLOGICA CORP NL5100; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL5100
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were artifacts in the image requiring the re-scan the patient.The customer did not properly calibrate the scanner, and it seems the phantom may have been misaligned.As corrective measure suggested the customers perform a qa check after every daily calibration until the facility gets used to the daily calibration phantom.There was no harm to the patient or user.Any additional information received on this incident will be reported in a follow-up mdr.
Event or Problem Description
The patient had to be rescanned due to artifact in the images.

• Brand Name: NL5100
• 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: 21503646
• Report Number: 3004938766-2025-00008
• Device Sequence Number: 14578134
• Product Code: JAK
• UDI-Device Identifier: 10815411020847
• UDI-Public: (01)10815411020847(11)250102
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: NL5100
• Device Catalogue Number: 0-NL5100-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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