VENTILATOR, CONTINUOUS, FACILITY USE
This device is manufactured by CAREFUSION, CAREFUSION 207 DBA CAREFUSION, VIASYS RESPIRATORY CARE, VYAIRE MEDICAL, VYAIRE MEDICAL MET.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unintended System Motion | 1 | Device |
| 2024 | Unexpected Shutdown | 1 | Device |
| 2024 | Tidal Volume Fluctuations | 2 | Device |
| 2024 | No Tactile Prompts/Feedback | 1 | Device |
| 2024 | No Display/Image | 4 | Device |
| 2024 | No Device Output | 3 | Device |
| 2024 | Medical Gas Supply Problem | 1 | Device |
| 2024 | Low Readings | 5 | Device |
| 2024 | Incorrect Measurement | 2 | Device |
| 2024 | Inaccurate Flow Rate | 2 | Device |
| 2024 | Gas/Air Leak | 1 | Device |
| 2024 | Gas Output Problem | 1 | Device |
| 2024 | Failure to Recalibrate | 2 | Device |
| 2024 | Failure to Conduct | 6 | Device |
| 2024 | Failure to Calibrate | 6 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Defective Component | 7 | Device |
| 2024 | Circuit Failure | 1 | Device |
| 2024 | Activation Failure | 1 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2023 | Tactile Prompts/Feedback | 2 | Device |
| 2023 | Smoking | 1 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | No Tactile Prompts/Feedback | 2 | Device |
| 2023 | Mechanical Problem | 87 | Device |
| 2023 | Leak/Splash | 3 | Device |
| 2023 | Infusion or Flow Problem | 1 | Device |
| 2023 | Inaccurate Flow Rate | 1 | Device |
| 2023 | Failure to Conduct | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 2 | Device |
| 2023 | Disconnection | 1 | Device |
| 2023 | Device Emits Odor | 1 | Device |
| 2023 | Defective Component | 5 | Device |
| 2023 | Decrease in Pressure | 1 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Circuit Failure | 1 | Device |
| 2023 | Calibration Problem | 2 | Device |
| 2023 | Activation Failure | 1 | Device |
| 2022 | Volume Accuracy Problem | 2 | Device |
| 2022 | Tactile Prompts/Feedback | 1 | Device |
| 2022 | Smoking | 1 | Device |
| 2022 | Protective Measures Problem | 1 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | No Display/Image | 1 | Device |
| 2022 | Mechanical Problem | 136 | Device |
| 2022 | Leak/Splash | 2 | Device |
| 2022 | Infusion or Flow Problem | 1 | Device |
| 2022 | Failure to Power Up | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 7 | Device |
| 2022 | Device Alarm System | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Mechanical Problem | 13 | Device |
| 2020 | Mechanical Problem | 1 | Device |