VENTILATOR, CONTINUOUS, FACILITY USE
This device is manufactured by RESPIRONICS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | No Display/Image | 1 | Device |
| 2024 | Mechanical Problem | 3 | Device |
| 2024 | Failure to Recalibrate | 3 | Device |
| 2024 | Failure to Charge | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 3 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Degraded | 2 | Device |
| 2024 | Circuit Failure | 2 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Battery Problem | 5 | Device |
| 2023 | Unspecified Respiratory Problem | 2 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Eye Irritation | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Degraded | 5 | Device |
| 2023 | Circuit Failure | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2022 | No Display/Image | 1 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Failure to Recalibrate | 3 | Device |
| 2022 | Failure to Charge | 5 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Circuit Failure | 2 | Device |
| 2022 | Battery Problem | 5 | Device |
| 2019 | Ventilation Problem in Device Environment | 1 | Device |
| 2019 | Unexpected Shutdown | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2019 | Temperature Problem | 2 | Device |
| 2019 | No Display/Image | 2 | Device |
| 2019 | Mechanical Problem | 16 | Device |
| 2019 | Leak/Splash | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | High Readings | 1 | Device |
| 2019 | Failure to Recalibrate | 15 | Device |
| 2019 | Failure to Charge | 6 | Device |
| 2019 | Degraded | 2 | Device |
| 2019 | Contamination | 1 | Device |
| 2019 | Computer Software Problem | 4 | Device |
| 2019 | Circuit Failure | 18 | Device |
| 2019 | Charging Problem | 1 | Device |
| 2019 | Battery Problem | 10 | Device |
| 2019 | Application Program Problem | 6 | Device |
| 2018 | Volume Accuracy Problem | 2 | Device |
| 2018 | Unexpected Shutdown | 1 | Device |
| 2018 | Temperature Problem | 1 | Device |
| 2018 | Pressure Problem | 2 | Device |
| 2018 | No Display/Image | 5 | Device |
| 2018 | Mechanical Problem | 10 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 10 | Device |
| 2018 | Failure to Recalibrate | 18 | Device |
| 2018 | Failure to Power Up | 3 | Device |
| 2018 | Failure to Charge | 15 | Device |
| 2018 | Failure To Run On AC/DC | 1 | Device |
| 2018 | Electrical /Electronic Property Problem | 2 | Device |
| 2018 | Device Operational Issue | 10 | Device |
| 2018 | Device Inoperable | 4 | Device |
| 2018 | Device Displays Incorrect Message | 6 | Device |
| 2018 | Degraded | 2 | Device |
| 2018 | Decrease in Pressure | 1 | Device |
| 2018 | Contamination | 2 | Device |
| 2018 | Connection Problem | 1 | Device |
| 2018 | Circuit Failure | 13 | Device |
| 2018 | Battery Problem | 17 | Device |
| 2018 | Application Program Problem | 1 | Device |
| 2017 | Tidal Volume Fluctuations | 2 | Device |
| 2017 | No Display/Image | 4 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 31 | Device |
| 2017 | Failure to Power Up | 1 | Device |
| 2017 | Failure to Charge | 15 | Device |
| 2017 | Disconnection | 2 | Device |
| 2017 | Device Stops Intermittently | 1 | Device |
| 2017 | Device Operational Issue | 32 | Device |
| 2017 | Device Inoperable | 6 | Device |
| 2017 | Device Displays Incorrect Message | 21 | Device |
| 2017 | Charging Problem | 1 | Device |
| 2017 | Battery Problem | 4 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2017 | Aborted Charge | 4 | Device |
| 2016 | Volume Accuracy Problem | 1 | Device |
| 2016 | Power Problem | 1 | Device |
| 2016 | No Display/Image | 7 | Device |
| 2016 | Leak/Splash | 1 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 24 | Device |
| 2016 | Failure to Charge | 18 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2016 | Device Operational Issue | 21 | Device |
| 2016 | Device Operates Differently Than Expected | 10 | Device |
| 2016 | Device Inoperable | 2 | Device |
| 2016 | Device Displays Incorrect Message | 10 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Charging Problem | 3 | Device |
| 2016 | Battery Problem | 9 | Device |
| 2016 | Appropriate Term/Code Not Available | 11 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2015 | Tidal Volume Fluctuations | 1 | Device |
| 2015 | No Display/Image | 1 | Device |
| 2015 | Moisture Damage | 1 | Device |
| 2015 | Failure to Power Up | 1 | Device |
| 2015 | Failure to Charge | 3 | Device |
| 2015 | Device Slipped | 1 | Device |
| 2015 | Device Sensing Problem | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 4 | Device |
| 2015 | Device Inoperable | 1 | Device |
| 2015 | Device Emits Odor | 1 | Device |
| 2015 | Device Displays Incorrect Message | 5 | Device |
| 2015 | Degraded | 1 | Device |
| 2015 | Break | 1 | Device |
| 2015 | Battery Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Pressure Problem | 1 | Device |
| 2014 | No Display/Image | 2 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 34 | Device |
| 2014 | Failure to Power Up | 8 | Device |
| 2014 | Failure to Deliver | 1 | Device |
| 2014 | Failure to Charge | 1 | Device |
| 2014 | Electrical /Electronic Property Problem | 3 | Device |
| 2014 | Device Operational Issue | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 3 | Device |
| 2014 | Device Inoperable | 6 | Device |
| 2014 | Device Displays Incorrect Message | 9 | Device |
| 2014 | Device Alarm System | 2 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Charging Problem | 1 | Device |
| 2014 | Break | 2 | Device |
| 2014 | Appropriate Term/Code Not Available | 13 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | No Flow | 1 | Device |
| 2013 | Insufficient Information | 1 | Device |
| 2013 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2013 | Device Maintenance Issue | 1 | Device |