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

Model Number NL5000

Device Problem Computer Software Problem (1112)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

It was determined during an onsite visit from a field service engineer (fse), the system completed daily calibration, and qa check, followed by four completed patient scans with no fault.On the fifth scan the system stopped, as reported by ct techs.The system completed a sixth scan with no fault, passed another daily calibration, and qa check.Per communication received from fse, an upgrade to the software version corrected the error the device experienced.It was found that even though the patient experienced an additional scan, the dose amount received is not considered to be harmful to the patient.

Event Description

Technician reported the scanner stopped intermittently in the middle of a scan on three different patients.

• Brand Name: OMNITOM
• 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: 11043009
• MDR Text Key: 227738250
• Report Number: 3004938766-2020-00015
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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