VENTILATOR, CONTINUOUS, FACILITY USE
This device is manufactured by CAREFUSION, CAREFUSION / VYAIRE MEDICAL, CAREFUSION 207 DBA CAREFUSION, CAREFUSION CORP, VIASYS RESPIRATORY CARE and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Low Oxygen Saturation | 1 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Unintended System Motion | 1 | Device |
| 2024 | Unintended Movement | 1 | Device |
| 2024 | Restricted Flow rate | 1 | Device |
| 2024 | No Visual Prompts/Feedback | 1 | Device |
| 2024 | No Display/Image | 1 | Device |
| 2024 | No Device Output | 3 | Device |
| 2024 | Low Readings | 5 | Device |
| 2024 | Incorrect Measurement | 3 | Device |
| 2024 | Inaccurate Delivery | 1 | Device |
| 2024 | High Readings | 4 | Device |
| 2024 | Gas/Air Leak | 4 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Failure to Sense | 1 | Device |
| 2024 | Failure to Recalibrate | 1 | Device |
| 2024 | Failure to Deliver | 1 | Device |
| 2024 | Failure to Calibrate | 1 | Device |
| 2024 | Erratic or Intermittent Display | 2 | Device |
| 2024 | Display Difficult to Read | 1 | Device |
| 2024 | Disconnection | 1 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Defective Component | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2024 | Activation Failure | 1 | Device |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Unexpected Shutdown | 2 | Device |
| 2023 | Tidal Volume Fluctuations | 1 | Device |
| 2023 | Tactile Prompts/Feedback | 3 | Device |
| 2023 | Pressure Problem | 2 | Device |
| 2023 | No Visual Prompts/Feedback | 1 | Device |
| 2023 | Mechanical Problem | 74 | Device |
| 2023 | Leak/Splash | 5 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Infusion or Flow Problem | 2 | Device |
| 2023 | Incorrect Measurement | 3 | Device |
| 2023 | Inaccurate Flow Rate | 1 | Device |
| 2023 | Improper Flow or Infusion | 1 | Device |
| 2023 | Gas/Air Leak | 1 | Device |
| 2023 | Free or Unrestricted Flow | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 5 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Decrease in Pressure | 1 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Complete Blockage | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Tactile Prompts/Feedback | 3 | Device |
| 2022 | Pumping Stopped | 1 | Device |
| 2022 | Pressure Problem | 1 | Device |
| 2022 | Melted | 1 | Device |
| 2022 | Mechanical Problem | 84 | Device |
| 2022 | Leak/Splash | 4 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inaccurate Delivery | 1 | Device |
| 2022 | Gas/Air Leak | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 3 | Device |
| 2021 | Mechanical Problem | 4 | Device |
| 2020 | No Visual Prompts/Feedback | 1 | Device |