MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

Model Number SYS-4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

Hospital staff called technical support at veran after the patient was intubated to troubleshoot the system beeping and screens not turning on.Recommended protocol for use of system is to confirm the system is working before patient is intubated.The staff had also already opened the sides of the system before calling technical support.After several troubleshooting steps where attempted with technical support, it became apparent that the cpu on the tower was not receiving power causing other hardware elements to beep from a lack of power even after the site's staff attempted to secure all plugs inside the system.Nothing further could be done to fix the tower at the time.Physician was only planning on doing a veran procedure so he did not complete the procedure.Procedure was rescheduled, cpu was replaced, and procedure was completed.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: SPIN THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: christine hardin ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 11148828
• MDR Text Key: 227747161
• Report Number: 3007222345-2020-00016
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 83746181011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR