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

Model Number	NL5000
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a ct tech broke their hand while driving the omnitom.
Additional Manufacturer Narrative
Neurologica immediately dispatched field service egineer to assess the issue.Based on the investigation completed by the fse, the technician was driving the system while holding the drive bar upside down with her thumbs facing out.As a corrective measure, technical training will be conducted to prevent similar incidents in the future.No additional information has been received on this incident.A follow-up report will be filed if any additional information is received.

• Brand Name: NL5000
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923
• MDR Report Key: 18029995
• Report Number: 3004938766-2023-00021
• Device Sequence Number: 14931100
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: 011081541102033511190905
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171183
• 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: Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NL5000
• Device Catalogue Number: 0-NL5000-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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