AISYS CS2

ANESTHESIA GAS MACHINE

This device is manufactured by DATEX-OHMEDA.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unexpected Therapeutic Results 17 Device
2024 Unexpected Shutdown 3 Device
2024 Therapeutic or Diagnostic Output Failure 10 Device
2024 Power Problem 2 Device
2024 No Flow 1 Device
2024 No Display/Image 9 Device
2024 Mechanical Problem 16 Device
2024 Leak/Splash 2 Device
2024 Insufficient Flow or Under Infusion 41 Device
2024 Increase in Pressure 3 Device
2024 Inappropriate or Unexpected Reset 1 Device
2024 Gas/Air Leak 4 Device
2024 Gas Output Problem 1 Device
2024 Failure to Run on Battery 12 Device
2024 Excess Flow or Over-Infusion 1 Device
2024 Electrical /Electronic Property Problem 3 Device
2024 Complete Loss of Power 1 Device
2023 Low Oxygen Saturation 1 Patient
2023 Insufficient Information 1 Patient
2023 Cyanosis 1 Patient
2023 Cardiac Arrest 1 Patient
2023 Brain Injury 1 Patient
2023 Unexpected Therapeutic Results 4 Device
2023 Unexpected Shutdown 8 Device
2023 Therapeutic or Diagnostic Output Failure 13 Device
2023 Suction Failure 1 Device
2023 Power Problem 1 Device
2023 No Visual Prompts/Feedback 2 Device
2023 No Flow 1 Device
2023 No Display/Image 9 Device
2023 No Audible Alarm 2 Device
2023 No Apparent Adverse Event 1 Device
2023 Mechanical Problem 15 Device
2023 Loss of Power 1 Device
2023 Leak/Splash 1 Device
2023 Insufficient Flow or Under Infusion 29 Device
2023 Infusion or Flow Problem 4 Device
2023 Increase in Pressure 1 Device
2023 Inaccurate Delivery 3 Device
2023 Image Display Error/Artifact 1 Device
2023 Failure to Run on Battery 12 Device
2023 Failure to Power Up 6 Device
2023 Electrical /Electronic Property Problem 9 Device
2023 Device Displays Incorrect Message 1 Device
2023 Battery Problem 1 Device
2023 Adverse Event Without Identified Device or Use Problem 1 Device
2022 Unexpected Therapeutic Results 4 Device
2022 Unexpected Shutdown 3 Device
2022 Therapeutic or Diagnostic Output Failure 16 Device
2022 Suction Failure 3 Device
2022 No Visual Prompts/Feedback 5 Device
2022 No Display/Image 12 Device
2022 No Audible Alarm 5 Device
2022 Mechanical Problem 14 Device
2022 Insufficient Flow or Under Infusion 1 Device
2022 Infusion or Flow Problem 2 Device
2022 Increase in Pressure 3 Device
2022 Gas/Air Leak 4 Device
2022 Failure to Run on Battery 8 Device
2022 Failure to Power Up 1 Device
2022 Device Displays Incorrect Message 3 Device
2022 Detachment of Device or Device Component 2 Device
2022 Decrease in Suction 5 Device
2022 Break 1 Device
2019 Unexpected Therapeutic Results 4 Device
2019 Unexpected Shutdown 4 Device
2019 Therapeutic or Diagnostic Output Failure 13 Device
2019 Suction Failure 2 Device
2019 Physical Resistance/Sticking 3 Device
2019 Output above Specifications 1 Device
2019 Output Problem 4 Device
2019 No Display/Image 1 Device
2019 No Audible Alarm 2 Device
2019 Mechanical Problem 11 Device
2019 Infusion or Flow Problem 13 Device
2019 Increase in Pressure 3 Device
2019 Incorrect, Inadequate or Imprecise Result or Readings 1 Device
2019 Inappropriate or Unexpected Reset 1 Device
2019 Inaccurate Delivery 1 Device
2019 Gas/Air Leak 5 Device
2019 Failure to Run on Battery 1 Device
2019 Device Fell 1 Device
2019 Detachment of Device or Device Component 1 Device
2019 Decrease in Suction 5 Device
2019 Decrease in Pressure 1 Device
2019 Crack 1 Device
2019 Break 9 Device
2019 Battery Problem 1 Device
2018 Unexpected Therapeutic Results 10 Device
2018 Unexpected Shutdown 4 Device
2018 Tidal Volume Fluctuations 4 Device
2018 Therapeutic or Diagnostic Output Failure 11 Device
2018 Suction Problem 14 Device
2018 Suction Failure 2 Device
2018 Pressure Problem 6 Device
2018 Physical Resistance/Sticking 7 Device
2018 Output Problem 37 Device
2018 No Flow 1 Device
2018 Mechanical Problem 11 Device
2018 Mechanical Jam 10 Device
2018 Loose or Intermittent Connection 1 Device
2018 Leak/Splash 8 Device
2018 Infusion or Flow Problem 3 Device
2018 Inflation Problem 1 Device
2018 Increase in Pressure 3 Device
2018 Incorrect, Inadequate or Imprecise Result or Readings 3 Device
2018 Inappropriate or Unexpected Reset 2 Device
2018 High Readings 2 Device
2018 Gas/Air Leak 1 Device
2018 Failure to Sense 1 Device
2018 Failure of Device to Self-Test 1 Device
2018 Energy Output Problem 9 Device
2018 Electrical /Electronic Property Problem 1 Device
2018 Device Operates Differently Than Expected 13 Device
2018 Device Inoperable 1 Device
2018 Device Displays Incorrect Message 5 Device
2018 Device Alarm System 6 Device
2018 Deformation Due to Compressive Stress 1 Device
2018 Defective Component 1 Device
2018 Break 28 Device
2018 Appropriate Term/Code Not Available 38 Device
2017 Suction Problem 13 Device
2017 Sticking 7 Device
2017 Pressure Problem 5 Device
2017 Obstruction of Flow 1 Device
2017 No Display/Image 2 Device
2017 Mechanical Problem 1 Device
2017 Loss of Power 1 Device
2017 Leak/Splash 14 Device
2017 Insufficient Flow or Under Infusion 1 Device
2017 Inadequate Lighting 1 Device
2017 Improper Flow or Infusion 1 Device
2017 High Readings 2 Device
2017 Excess Flow or Over-Infusion 4 Device
2017 Disconnection 1 Device
2017 Device Operates Differently Than Expected 75 Device
2017 Device Inoperable 9 Device
2017 Device Displays Incorrect Message 4 Device
2017 Device Alarm System 14 Device
2017 Break 2 Device
2017 Appropriate Term/Code Not Available 35 Device
2016 Suction Problem 7 Device
2016 Pressure Problem 7 Device
2016 Nonstandard Device 1 Device
2016 Mechanical Problem 4 Device
2016 Low Audible Alarm 1 Device
2016 Leak/Splash 1 Device
2016 Insufficient Flow or Under Infusion 1 Device
2016 Increase in Pressure 1 Device
2016 Inaccurate Delivery 1 Device
2016 Improper Flow or Infusion 1 Device
2016 Excess Flow or Over-Infusion 2 Device
2016 Device Operates Differently Than Expected 37 Device
2016 Device Inoperable 2 Device
2016 Device Alarm System 6 Device
2016 Crack 1 Device
2016 Computer Operating System Problem 2 Device
2016 Appropriate Term/Code Not Available 10 Device
2016 Alarm Not Visible 1 Device
2015 No Display/Image 2 Device
2015 Device Operates Differently Than Expected 1 Device
2015 Data Problem 1 Device
2015 Computer Operating System Problem 1 Device
2014 Appropriate Term/Code Not Available 1 Device