MAUDE Adverse Event Report: KUB TECHNOLOGIES, INC MOZART 3D SPECIMEN TOMOSYNTHESIS; CABINET- X-RAY SYSTEM

Model Number	XPERT42
Medical Device Problem Code	Operating System Version or Upgrade Problem (2997)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The company received a medwatch report from fda on 12/30/2022 that was filed by a healthcare facility.The report (# mw5113921) alleged that there were problems with the mozart xpert 42 system during surgical cases.The report alleged that the system started performing an automatic update during use resulting in the screens going black, loss of imaging and inability to identify the location of implanted tissue marker clips.As a result the patient had to return to have a second surgery to remove cancerous tissue.
Additional Manufacturer Narrative
This is to acknowledge receipt of the medwatch report sent by fda that was originated by a healtchare facility.The device had been installed and left at the facility meeting all installation requirements with the automated update function turned off.The customer was informed in past to work with their it department and leave the automated update function off and have updates performed when equipment is not in use.Kubtec is working with the customer to ensure original settings are maintained to avoid automatic updates from occurring during usage.

• Brand Name: MOZART 3D SPECIMEN TOMOSYNTHESIS
• Common Device Name: CABINET- X-RAY SYSTEM
• Manufacturer (Section D): KUB TECHNOLOGIES, INC; 111 research drive; stratford CT 06615
• Manufacturer (Section G): KUB TECHNOLOGIES INC; 111 research drive; stratford CT 06615
• Manufacturer Contact: chester lowe ; 111 research drive; stratford, CT 06615 ; 2033648544
• MDR Report Key: 16214026
• Report Number: 3006051164-2023-00001
• Device Sequence Number: 17235793
• Product Code: MWP
• UDI-Device Identifier: B619X420
• UDI-Public: B619X420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: XPERT42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown