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

Model Number NL4000

Device Problems Computer Software Problem (1112); Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 10/26/2019

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident was found to be related to the control software, which stopped responding.Neurologica is still conducting an investigation to determine the exact reason for this incident.After review of the device history logs, it has been confirmed that x-ray was not firing even though the x-ray light was showing as on.No harm to the patient or user was stated, as there was no x-ray firing so no radiation was received.The field service representative confirmed the device to be functioning properly, as well as the burning smell was gone.The likelihood of patient/user injury is negligible currently.Future service calls will be monitored for similar incidents in the field.

Event Description

The customer reported that while performing an air calibration, the computed tomography (ct) system started to fire continuously without stopping.The customer tried to press the emergency stop button to halt all device actions, however, that did not seem to work.The device eventually turned off after the user attempted to press the on/off button again.The customer claimed they could smell a burning smell from the 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: 12872334
• MDR Text Key: 283170382
• Report Number: 3004938766-2021-00018
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K102677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/24/2021

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: 10/26/2021
• Initial Date FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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