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

Model Number NL4000

Device Problems Computer Software Problem (1112); Application Program Problem (2880)

Patient Problems Patient Problem/Medical Problem (2688); Radiation Exposure, Unintended (3164)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

There was no injury to the patient.After the system malfunction, a reboot was attempted, but had to wait for x-ray tube to cool before it will allow a shutdown.After restarting the scanner and running the scouts and primary scan, the systems failed again.Our field service engineer arrived on site and another scout scan without any issues.The completed procedure showed the x-ray tube had issues.Awaiting further analysis, pending return of the suspected component, an rma will be used to track and record the findings for this unit.As per our calculation, cumulative ctdivol of 204 mgy and dlp 2168 mgy.Cm was delivered to the patient.Software patch will be created to address the issue.

Event Description

Bodytom elite ct system failed during an interventional scan while patient was under anesthesia.

• Brand Name: BODYTOM ELITE
• 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: 9175447
• MDR Text Key: 194484744
• Report Number: 3004938766-2019-00005
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NL4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• 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