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

Model Number NL3000

Device Problem Connection Problem (2900)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

While field service engineer was examining the laptop, all diagnostics passed.However, it was noticed that the laptop had several applications running, which may have caused the laptop to run slowly.While the field service engineer was reviewing the computer logs, it was observed that there was a disconnect when the scout scan was running.The ceretom application seem to function after the technician reviewed the issue.Even though the patient underwent two scout scans, the dose amount received is well below the dose threshold and is not considered harmful to the patient.

Event Description

During the initial scout scan of a patient, the scout image was not received by the laptop computer.The technician completed a second scout scan and received the image.

• Brand Name: CERETOM ELITE
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM, PRODUCT CODE:
• 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 ; 9785648632
• MDR Report Key: 11043010
• MDR Text Key: 228052612
• Report Number: 3004938766-2020-00016
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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