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

Model Number NL5000

Device Problems Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/03/2019

Event Type  malfunction  

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 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
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: roberto cunha ; 14 electronics avenue; danvers, MA 01923 ; 9785648500
• MDR Report Key: 8559955
• MDR Text Key: 143396379
• Report Number: 3004938766-2019-00001
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: 011081541102033511190123
• 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 Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: NL5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other