CARESTATION 650

ANESTHESIA GAS MACHINE

This device is manufactured by GE MEDICAL SYSTEMS (CHINA) CO (WUXI), HERAEUS KULZER GMBH.

The following problems were reported about this device:

Year Description Events/year Type
2024 Low Oxygen Saturation 1 Patient
2024 Unexpected Therapeutic Results 7 Device
2024 Unexpected Shutdown 3 Device
2024 Therapeutic or Diagnostic Output Failure 19 Device
2024 Pressure Problem 1 Device
2024 Power Problem 4 Device
2024 No Flow 1 Device
2024 No Display/Image 8 Device
2024 Mechanical Problem 9 Device
2024 Leak/Splash 1 Device
2024 Insufficient Flow or Under Infusion 2 Device
2024 Gas/Air Leak 2 Device
2024 Failure to Run on Battery 24 Device
2024 Failure to Deliver 1 Device
2024 Electrical /Electronic Property Problem 2 Device
2024 Display or Visual Feedback Problem 1 Device
2024 Complete Loss of Power 1 Device
2023 Asystole 1 Patient
2023 Unexpected Therapeutic Results 7 Device
2023 Unexpected Shutdown 4 Device
2023 Therapeutic or Diagnostic Output Failure 35 Device
2023 Pressure Problem 1 Device
2023 Power Problem 7 Device
2023 No Visual Prompts/Feedback 2 Device
2023 No Display/Image 11 Device
2023 No Audible Alarm 1 Device
2023 Mechanical Problem 20 Device
2023 Insufficient Information 1 Device
2023 Insufficient Flow or Under Infusion 20 Device
2023 Increase in Pressure 1 Device
2023 Inaccurate Delivery 6 Device
2023 Gas/Air Leak 3 Device
2023 Failure to Run on Battery 32 Device
2023 Failure to Power Up 6 Device
2023 Electrical /Electronic Property Problem 7 Device
2023 Complete Loss of Power 2 Device
2023 Break 1 Device
2022 Unexpected Shutdown 3 Device
2022 Therapeutic or Diagnostic Output Failure 20 Device
2022 Suction Failure 3 Device
2022 No Visual Prompts/Feedback 3 Device
2022 No Display/Image 11 Device
2022 No Audible Alarm 1 Device
2022 Mechanical Problem 19 Device
2022 Insufficient Information 1 Device
2022 Increase in Pressure 1 Device
2022 Inaccurate Delivery 2 Device
2022 Gas/Air Leak 2 Device
2022 Failure to Run on Battery 11 Device
2022 Decrease in Suction 1 Device
2022 Break 1 Device
2019 Unexpected Therapeutic Results 3 Device
2019 Unexpected Shutdown 1 Device
2019 Therapeutic or Diagnostic Output Failure 24 Device
2019 Suction Failure 1 Device
2019 Physical Resistance/Sticking 6 Device
2019 Mechanical Problem 4 Device
2019 Infusion or Flow Problem 3 Device
2019 Increase in Pressure 1 Device
2019 Inappropriate or Unexpected Reset 1 Device
2019 Inaccurate Delivery 1 Device
2019 Gas/Air Leak 3 Device
2019 Energy Output Problem 1 Device
2019 Defective Alarm 1 Device
2019 Decrease in Suction 3 Device
2019 Break 1 Device
2019 Battery Problem 1 Device
2018 Unexpected Therapeutic Results 4 Device
2018 Therapeutic or Diagnostic Output Failure 2 Device
2018 Suction Problem 2 Device
2018 Self-Activation or Keying 1 Device
2018 Output Problem 7 Device
2018 No Display/Image 2 Device
2018 Mechanical Problem 7 Device
2018 Mechanical Jam 1 Device
2018 Loss of Power 1 Device
2018 Leak/Splash 7 Device
2018 Incorrect, Inadequate or Imprecise Result or Readings 1 Device
2018 High Readings 1 Device
2018 Device Operates Differently Than Expected 7 Device
2018 Device Displays Incorrect Message 7 Device
2018 Device Alarm System 1 Device
2018 Communication or Transmission Problem 1 Device
2018 Collapse 1 Device
2018 Circuit Failure 1 Device
2018 Appropriate Term/Code Not Available 12 Device
2017 Tidal Volume Fluctuations 1 Device
2017 Suction Problem 3 Device
2017 Sticking 1 Device
2017 Mechanical Problem 1 Device
2017 Loss of Power 1 Device
2017 Leak/Splash 11 Device
2017 Insufficient Information 1 Device
2017 High Readings 1 Device
2017 Failure to Power Up 1 Device
2017 Failure to Calibrate 2 Device
2017 Failure of Device to Self-Test 1 Device
2017 Excess Flow or Over-Infusion 16 Device
2017 Device Operates Differently Than Expected 39 Device
2017 Device Inoperable 1 Device
2017 Device Displays Incorrect Message 9 Device
2017 Device Alarm System 2 Device
2017 Computer Operating System Problem 1 Device
2017 Communication or Transmission Problem 1 Device
2017 Appropriate Term/Code Not Available 24 Device
2016 Suction Problem 1 Device
2016 Pressure Problem 1 Device
2016 Leak/Splash 1 Device
2016 Invalid Sensing 1 Device
2016 Device Stops Intermittently 1 Device
2016 Device Operates Differently Than Expected 16 Device
2016 Device Inoperable 2 Device
2016 Device Displays Incorrect Message 3 Device
2016 Device Alarm System 3 Device
2016 Appropriate Term/Code Not Available 2 Device
2015 Appropriate Term/Code Not Available 1 Device