MAUDE Adverse Event Report: NEUROLOGICA CORP., A SUBSIDIARY OF SAMSUNG ELECTRONICS CO., LTD. OMNITOM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number OMNITOM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 07/10/2021

Event Type  Injury  

Event Description

This report is not directly related to a patient.A staff member was maneuvering a portable ct unit through a doorway.The unit abruptly moved sideways in the door and pinned the leg of the staff member between the unit and door.The staff member suffered an avulsion fracture and also required stitches.The unit was serviced by the vendor the day before and was determined to be operating as designed.Fda safety report id# (b)(4).

• Brand Name: OMNITOM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): NEUROLOGICA CORP., A SUBSIDIARY OF SAMSUNG ELECTRONICS CO., LTD.; danvers MA 01923
• MDR Report Key: 12331729
• MDR Text Key: 267087354
• Report Number: MW5103289
• Device Sequence Number: 1
• Product Code: JAK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OMNITOM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other