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

Model Number NL5000

Device Problems Inadequate or Insufficient Training (1643); Positioning Problem (3009)

Patient Problems Crushing Injury (1797); Bone Fracture(s) (1870)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

It was determined that this incident was user induced.The user was not driving the device appropriately based on the instructions for use.Based on information received from the customer, the user did not have both hands on the drive bar of the device.The user manual instructs the user to place both hands on the drive bar while moving the device.To help mitigate this issue, the site has been offered additional training to ensure all users are well aware of how to use the device safely.

Event Description

It was reported that while a technician was completing a ct scan, her hand got pinned between the wall and the device.The technician said when she attempted to move the device forward her hand was compressed against the wall, causing injury.

• 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: 12257163
• MDR Text Key: 264480829
• Report Number: 3004938766-2021-00009
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2021
• 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: 06/29/2021
• 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
• Patient Outcome(s): Other