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

Model Number NL4000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Because the user had to repeat scans on both patients on another device, it was determined that the additional dose delivered to each patient based on the helical protocol used was (b)(4).The root cause of the incident was concluded to be a device malfunction.The required components were replaced and the field service representative confirmed the device to be functioning properly after the component replacement.Service calls will be monitored going forward for similar events and escalated if required.

Event Description

The customer reported that there were abnormal images and errors after patient scans and as a result two patients required rescanning on another scanner.

• Brand Name: BODYTOM
• Type of Device: 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 ; 9785648632
• MDR Report Key: 15395064
• MDR Text Key: 306000139
• Report Number: 3004938766-2022-00005
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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