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

Model Number NL5000

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

There was a malfunction with the scanner, which caused a delay in the patient's treatment.

Manufacturer Narrative

Patient was transported to the hospital due to malfunction in the mobile stroke unit's ct scanner.The affected ct scanner parts were replaced to resolve the issue.

• Brand Name: NL5000
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; 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: 18947185
• MDR Text Key: 338560674
• Report Number: 3004938766-2024-00012
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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
• Date Manufacturer Received: 02/23/2024
• Date Device Manufactured: 08/12/2023
• 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