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

Model Number NL5000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Upon root cause analysis by our service technician and review of the logs, failure of certain parts was confirmed which caused supplemental issues to manifest.The scanner got stuck and was not able to properly power down (i.E.Reboot).Multiple components on the system needed to be replaced as a result.Also even though the scan was completed the images were not transferred and hence the patient therefore had to be re-scanned (120kv, 45 ma , slices 5 mm) which resulted in additional 167.22 mgy dose to the patient.

Event Description

The omnitom computed tomography (ct) system had some screen issues during scans as the lcd kept shutting off.The scan was completed but images could not be sent due to machine issues (the tablet back would not turn back on).The scanner malfunctioned after the scan was finished and was unable to be rebooted.The system was close to the doorway blocking access.No user or patient injury reported.

• 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: 9465155
• MDR Text Key: 209265929
• Report Number: 3004938766-2019-00007
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL5000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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