ASTRAL 150 - FUKUDA

VENTILATOR, CONTINUOUS (FACILITY/HOME)

This device is manufactured by RESMED, RESMED CORP, RESMED PTY.

The following problems were reported about this device:

Year Description Events/year Type
2024 Low Oxygen Saturation 4 Patient
2024 Unexpected Therapeutic Results 4 Device
2024 Therapeutic or Diagnostic Output Failure 2 Device
2024 Protective Measures Problem 17 Device
2024 Inadequate User Interface 2 Device
2024 Display or Visual Feedback Problem 2 Device
2023 Insufficient Information 1 Patient
2023 Temperature Problem 1 Device
2023 Protective Measures Problem 1 Device
2023 Failure of Device to Self-Test 2 Device
2023 Device Displays Incorrect Message 1 Device
2023 Complete Loss of Power 2 Device
2023 Battery Problem 2 Device
2022 Unexpected Therapeutic Results 2 Device
2022 Protective Measures Problem 9 Device
2022 Output Problem 1 Device
2022 Mechanical Problem 1 Device
2022 Inadequate User Interface 2 Device
2022 Failure to Power Up 2 Device
2022 Failure of Device to Self-Test 14 Device
2022 Display or Visual Feedback Problem 6 Device
2022 Device Displays Incorrect Message 5 Device
2022 Complete Loss of Power 4 Device
2021 Failure of Device to Self-Test 4 Device
2021 Display or Visual Feedback Problem 1 Device
2021 Device Displays Incorrect Message 1 Device
2020 Protective Measures Problem 4 Device
2020 Pressure Problem 1 Device
2020 Failure to Power Up 1 Device
2020 Data Problem 1 Device
2019 Unexpected Shutdown 5 Device
2019 Therapeutic or Diagnostic Output Failure 2 Device
2019 Reset Problem 1 Device
2019 Protective Measures Problem 12 Device
2019 Power Problem 2 Device
2019 Obstruction of Flow 1 Device
2019 No Display/Image 1 Device
2019 Inappropriate or Unexpected Reset 1 Device
2019 Inadequate User Interface 2 Device
2019 Failure to Power Up 1 Device
2019 Failure to Charge 2 Device
2019 Failure to Calibrate 24 Device
2019 Display or Visual Feedback Problem 2 Device
2019 Device Stops Intermittently 1 Device
2019 Device Misassembled During Manufacturing /Shipping 1 Device
2019 Device Inoperable 1 Device
2019 Device Displays Incorrect Message 3 Device
2019 Defective Alarm 1 Device
2019 Complete Loss of Power 1 Device
2019 Charging Problem 1 Device
2019 Battery Problem 3 Device
2019 Alarm Not Visible 1 Device
2018 Unexpected Shutdown 2 Device
2018 Therapeutic or Diagnostic Output Failure 1 Device
2018 Protective Measures Problem 18 Device
2018 Pressure Problem 1 Device
2018 Power Problem 23 Device
2018 No Display/Image 8 Device
2018 Intermittent Loss of Power 1 Device
2018 Insufficient Information 1 Device
2018 Failure to Power Up 2 Device
2018 Failure to Charge 4 Device
2018 Failure to Calibrate 220 Device
2018 Display or Visual Feedback Problem 4 Device
2018 Device Stops Intermittently 10 Device
2018 Device Inoperable 5 Device
2018 Device Displays Incorrect Message 36 Device
2018 Complete Loss of Power 1 Device
2018 Charging Problem 15 Device
2018 Battery Problem 30 Device
2017 Power Problem 27 Device
2017 No Display/Image 6 Device
2017 Material Deformation 2 Device
2017 Inappropriate or Unexpected Reset 1 Device
2017 Failure to Charge 1 Device
2017 Failure to Calibrate 144 Device
2017 Device Stops Intermittently 6 Device
2017 Device Inoperable 6 Device
2017 Device Displays Incorrect Message 50 Device
2017 Charging Problem 26 Device
2017 Battery Problem 13 Device
2016 Failure to Charge 1 Device
2016 Failure to Calibrate 75 Device
2016 Device Stops Intermittently 2 Device
2016 Device Displays Incorrect Message 9 Device
2016 Device Alarm System 1 Device
2016 Battery Problem 2 Device
2015 No Display/Image 2 Device
2015 Failure to Calibrate 1 Device
2015 Device Inoperable 2 Device
2014 Failure to Calibrate 1 Device