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

Model Number NL5000

Device Problem Human-Device Interface Problem (2949)

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

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

The omnitom ct system has significant weight and size.We are releasing a service bulletin for customer that highlights people to get familiarized with the omnitom drive system and to refrain from maneuvering/driving the system in space restricted locations.

Event Description

During navigation of the omnitom ct system, technologist was unable to get the omnitom to turn or do anything other than go backward.This resulted in the technologist getting backed up against a sink.After several minutes the technologist was able to get the system to turn however the ct system kept stopping while transporting it to the storage location.No patients were harmed a result of this incident however the technologist had some bruising.

• 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: roberto cunha ; 14 electronics avenue; danvers, MA 01923 ; 9785648500
• MDR Report Key: 8605695
• MDR Text Key: 145113922
• Report Number: 3004938766-2019-00002
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: 011081541102033511180828
• 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
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other