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

Model Number NL5000

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Human-Device Interface Problem (2949)

Patient Problem Bruise/Contusion (1754)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Field service engineer investigated device and showed the device was functioning properly.No errors were noted in the logs.The field service engineer stated that the device passed all successful driving tests.After review, the incident seemed to be due to user error.Field service has set up training to ensure users are well equipped to use the device appropriately.

Event Description

User tried to drive device into the room where scan was going to take place.The device moved in a diagonal manner, instead of moving straight, and it resulted in the technician who was driving the device to get their hand caught in between the device and the door.There was noticeable redness and brusing upon release of the technicians hand.

• 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: 11346879
• MDR Text Key: 232527194
• Report Number: 3004938766-2021-00002
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NL5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2018
• 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