VOCSN

VENTILATOR, CONTINUOUS, FACILITY USE

This device is manufactured by VENTEC LIFE SYSTEMS.

The following problems were reported about this device:

Year Description Events/year Type
2024 Low Oxygen Saturation 2 Patient
2024 Insufficient Information 1 Patient
2024 Unexpected Shutdown 20 Device
2024 Output Problem 71 Device
2024 No Display/Image 1 Device
2024 Insufficient Information 1 Device
2024 Inaccurate Delivery 3 Device
2024 Display or Visual Feedback Problem 3 Device
2024 Device Alarm System 2 Device
2024 Connection Problem 13 Device
2023 Low Oxygen Saturation 2 Patient
2023 Insufficient Information 4 Patient
2023 Discomfort 3 Patient
2023 Unexpected Shutdown 23 Device
2023 Smoking 1 Device
2023 Patient Device Interaction Problem 1 Device
2023 Output Problem 181 Device
2023 No Display/Image 2 Device
2023 Material Separation 3 Device
2023 Insufficient Information 4 Device
2023 Inaccurate Delivery 4 Device
2023 Display or Visual Feedback Problem 20 Device
2023 Device Alarm System 3 Device
2023 Connection Problem 21 Device
2023 Break 1 Device
2023 Adverse Event Without Identified Device or Use Problem 1 Device
2022 Unexpected Shutdown 15 Device
2022 Power Problem 4 Device
2022 Output Problem 171 Device
2022 No Display/Image 5 Device
2022 No Audible Alarm 1 Device
2022 No Apparent Adverse Event 1 Device
2022 Improper Flow or Infusion 2 Device
2022 Display or Visual Feedback Problem 20 Device
2022 Defective Alarm 1 Device
2022 Connection Problem 16 Device
2021 Unexpected Shutdown 3 Device
2021 Power Problem 1 Device
2021 Output Problem 31 Device
2021 No Visual Prompts/Feedback 1 Device
2021 No Display/Image 3 Device
2021 Insufficient Information 2 Device
2021 Improper Flow or Infusion 1 Device
2021 Display or Visual Feedback Problem 5 Device
2021 Device Alarm System 1 Device
2021 Connection Problem 8 Device
2020 Output Problem 1 Device
2019 Unexpected Shutdown 12 Device
2019 Therapeutic or Diagnostic Output Failure 2 Device
2019 Output Problem 4 Device
2019 No Audible Alarm 1 Device
2018 Unexpected Shutdown 2 Device
2018 Output Problem 1 Device
2018 Device Inoperable 1 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device