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

Model Number NL4000

Device Problems Failure to Calibrate (2440); Environmental Particulates (2930)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Upon root cause analysis by neurologica's service technician, it was determined dust in the device caused the scan failure and delay in patient treatment.Per instructions from the service technician, the device was cleaned and recalibrated, in which after it was confirmed to be functioning normally.The patient was a child with fever and as a result of the device malfunction, was transferred to another ct device to complete required scanning.Even though the patient was in the bore when the scan failure occured, there was no reported impact to the patient's condition.The incident was reported two months after the date of the incident, resulting in a delay in mdr submission.Future service calls will be monitored for such incidents and escalated if necessary.

Event Description

The customer reported that as they were setting up a pediatric patient to be scanned, the device displayed an error message and as a result, the patient could not be scanned.The device failure caused scanning delay.There was no reported injury to the patient.

• Brand Name: BODYTOM
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORP; 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: 13471201
• MDR Text Key: 285162461
• Report Number: 3004938766-2022-00001
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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