CRITICAL CARE VENTILATER
This device is manufactured by DATEX-OHMEDA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Low Oxygen Saturation | 3 | Patient |
| 2024 | Unexpected Therapeutic Results | 8 | Device |
| 2024 | Therapeutic or Diagnostic Output Failure | 8 | Device |
| 2024 | Power Problem | 11 | Device |
| 2024 | No Visual Prompts/Feedback | 1 | Device |
| 2024 | No Flow | 1 | Device |
| 2024 | No Display/Image | 18 | Device |
| 2024 | Mechanical Problem | 13 | Device |
| 2024 | Insufficient Flow or Under Infusion | 99 | Device |
| 2024 | Infusion or Flow Problem | 1 | Device |
| 2024 | Increase in Pressure | 4 | Device |
| 2024 | Failure to Run on Battery | 45 | Device |
| 2024 | Failure to Power Up | 3 | Device |
| 2024 | Electrical /Electronic Property Problem | 4 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Calibration Problem | 1 | Device |
| 2023 | Low Oxygen Saturation | 1 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Unexpected Therapeutic Results | 9 | Device |
| 2023 | Unexpected Shutdown | 3 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 10 | Device |
| 2023 | Power Problem | 17 | Device |
| 2023 | No Visual Prompts/Feedback | 1 | Device |
| 2023 | No Display/Image | 25 | Device |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Mechanical Problem | 12 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Insufficient Flow or Under Infusion | 62 | Device |
| 2023 | Gas/Air Leak | 1 | Device |
| 2023 | Failure to Shut Off | 1 | Device |
| 2023 | Failure to Run on Battery | 205 | Device |
| 2023 | Failure to Power Up | 7 | Device |
| 2023 | Electrical /Electronic Property Problem | 6 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Calibration Problem | 4 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2022 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | No Visual Prompts/Feedback | 1 | Device |
| 2022 | No Display/Image | 16 | Device |
| 2022 | Failure to Run on Battery | 251 | Device |
| 2022 | Display Difficult to Read | 1 | Device |
| 2022 | Battery Problem | 2 | Device |
| 2020 | Failure to Run on Battery | 3 | Device |