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

Model Number NL5000

Device Problems Display or Visual Feedback Problem (1184); Calibration Problem (2890)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Upon review by the field service engineer, it was noted that the system was not reaching the correct distance while completing the scan.Since the expected number of images were not received, the user had to repeat the scan, resulting in the patient receiving additional radiation.It was determined that the root cause was due to the wheels not functioning properly.The wheels and necessary components were replaced.It was ensured that the wheels were calibrated and functioning properly prior to placing the system back in service.Since the patient was re-scanned, as per our calculation the patient received a total dose of 83.60 mgy.

Event Description

After an initial scan of a patient, the user did not receive all of the images from the selected protocol.The user then initiated a second scan, and again did not receive all images per the protocol chosen.It was determined that the scanner was not completing the accurate distance of the scan due to the wheels being out of calibration.Because a second scan was initiated by the user, the patient received additional radiation.

• Brand Name: OMNITOM
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• MDR Report Key: 11832868
• MDR Text Key: 258679210
• Report Number: 3004938766-2021-00007
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K171183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL5000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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