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

Model Number NL3000

Device Problem No Display/Image (1183)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Upon root cause analysis by our service technician, it was found that the exam was never closed/finalized, nor was the laptop shut off.There was confusion about how to get images from the software if there is a wireless disconnect.All scans were found.Additional training for customer to navigate the software.No signs of patient harm or delay.

Event Description

The customer recently had some issues with nl3000, the images were lost after the scan had been completed.The scans were done, and images were scrolled through and reviewed.When scanner was brought back to the ct area for transmission to pacs, the images were unable to be located.

• Brand Name: CERETOM ELITE
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers, ma
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers, ma
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, ma ; 5648632
• MDR Report Key: 10216321
• MDR Text Key: 198712229
• Report Number: 3004938766-2020-00006
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1