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

Model Number	NL5000
Medical Device Problem Codes	Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The omnitom ct system issue was reproduced on site by service engineer leaning on the drive bar during calibration at power up, the system was re-started and worked as intended.Daily and qa calibration successfully passed during the visit.Upon diagnosis, if the user touched the drive bar during calibration at power up, it would result in erroneous calibration, producing erratic driving behavior for the ct system.Omnitom user manual rev 3 page 69 cautions the user to not lean on the drive bar during calibration at power up.The following corrective actions are undertaken by our engineering team to prevent recurrence of this issue: update the software to check for prior position of the drive bar and not proceed with calibration if the drive bar is out of range, display message on lcd to not touch drive bar during calibration, and add label to ct system to not touch the drive bar during calibration.(b)(4).
Event or Problem Description
Customer stated that the omnitom ct system jumped forward when driving.Several attempts to drive the system failed.The ct system was left on and lodged in the corner of the storage room as the system was driving erratically.No patients or staff were harmed as a result of this incident.

• Brand Name: OMNITOM
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers 01923
• MDR Report Key: 8559955
• Report Number: 3004938766-2019-00001
• Device Sequence Number: 19216613
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: 011081541102033511190123
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K171183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: NL5000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other