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

Model Number NL5000

Device Problem Insufficient Information (3190)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The patient required a rescan on a different machine due to a system error.We are investigating the cause of the issue and working on implementing corrective measures to mitigate the risk and prevent errors.Any additional information received on this incident will be reported in a follow-up mdr.

Event Description

The scanner stopped mid-scan and failed to complete the patient scan due to system error.The patient had to be rescanned.

• Brand Name: NL5000
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORP; 14 electronics ave; 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: 18890869
• MDR Text Key: 337592618
• Report Number: 3004938766-2024-00008
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NL5000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1