VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
This device is manufactured by FLIGHT MEDICAL INNOVATIONS, PHILIPS, PHILIPS HEALTHCARE, PHILIPS HEALTHCARE / INNER COOL, PHILIPS HEALTHCARE / RESPIRONICS and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Vascular Problem | 1 | Patient |
| 2024 | Unspecified Respiratory Problem | 1 | Patient |
| 2024 | Low Oxygen Saturation | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Unstable | 4 | Device |
| 2024 | Unintended Power Up | 1 | Device |
| 2024 | Unexpected Shutdown | 3 | Device |
| 2024 | Tidal Volume Fluctuations | 7 | Device |
| 2024 | Power Problem | 2 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | No Display/Image | 5 | Device |
| 2024 | No Audible Alarm | 1 | Device |
| 2024 | Moisture or Humidity Problem | 1 | Device |
| 2024 | Mechanical Problem | 6 | Device |
| 2024 | Insufficient Flow or Under Infusion | 1 | Device |
| 2024 | Infusion or Flow Problem | 1 | Device |
| 2024 | Increase in Pressure | 3 | Device |
| 2024 | Inadequate User Interface | 43 | Device |
| 2024 | Image Display Error/Artifact | 1 | Device |
| 2024 | Grounding Malfunction | 6 | Device |
| 2024 | Gas/Air Leak | 7 | Device |
| 2024 | Failure to Sense | 21 | Device |
| 2024 | Failure to Run on Battery | 11 | Device |
| 2024 | Failure to Power Up | 5 | Device |
| 2024 | Failure to Deliver | 6 | Device |
| 2024 | Failure to Charge | 3 | Device |
| 2024 | Excessive Heating | 2 | Device |
| 2024 | Excess Flow or Over-Infusion | 1 | Device |
| 2024 | Erratic or Intermittent Display | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 4 | Device |
| 2024 | Display Difficult to Read | 1 | Device |
| 2024 | Device Sensing Problem | 7 | Device |
| 2024 | Device Markings/Labelling Problem | 1 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2024 | Device Alarm System | 17 | Device |
| 2024 | Defective Alarm | 1 | Device |
| 2024 | Computer Software Problem | 3 | Device |
| 2024 | Complete Loss of Power | 8 | Device |
| 2024 | Communication or Transmission Problem | 3 | Device |
| 2024 | Battery Problem | 3 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Hypoxia | 2 | Patient |
| 2023 | Volume Accuracy Problem | 6 | Device |
| 2023 | Unstable | 1 | Device |
| 2023 | Unintended Power Up | 9 | Device |
| 2023 | Unexpected Shutdown | 32 | Device |
| 2023 | Unable to Obtain Readings | 1 | Device |
| 2023 | Tidal Volume Fluctuations | 9 | Device |
| 2023 | Temperature Problem | 1 | Device |
| 2023 | Smoking | 1 | Device |
| 2023 | Protective Measures Problem | 1 | Device |
| 2023 | Pressure Problem | 1 | Device |
| 2023 | Power Problem | 22 | Device |
| 2023 | Poor Quality Image | 2 | Device |
| 2023 | Overheating of Device | 1 | Device |
| 2023 | Operating System Becomes Nonfunctional | 1 | Device |
| 2023 | Obstruction of Flow | 4 | Device |
| 2023 | No Flow | 6 | Device |
| 2023 | No Display/Image | 16 | Device |
| 2023 | No Audible Alarm | 2 | Device |
| 2023 | Mechanical Problem | 11 | Device |
| 2023 | Mechanical Jam | 3 | Device |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Insufficient Flow or Under Infusion | 6 | Device |
| 2023 | Infusion or Flow Problem | 3 | Device |
| 2023 | Increase in Pressure | 3 | Device |
| 2023 | Incomplete or Inadequate Connection | 1 | Device |
| 2023 | Inadequate User Interface | 103 | Device |
| 2023 | Inaccurate Flow Rate | 1 | Device |
| 2023 | Inaccurate Delivery | 1 | Device |
| 2023 | Improper Flow or Infusion | 4 | Device |
| 2023 | Grounding Malfunction | 5 | Device |
| 2023 | Gas/Air Leak | 28 | Device |
| 2023 | Gas Output Problem | 1 | Device |
| 2023 | Fitting Problem | 1 | Device |
| 2023 | Fire | 1 | Device |
| 2023 | False Alarm | 1 | Device |
| 2023 | Failure to Shut Off | 6 | Device |
| 2023 | Failure to Sense | 14 | Device |
| 2023 | Failure to Run on Battery | 11 | Device |
| 2023 | Failure to Read Input Signal | 2 | Device |
| 2023 | Failure to Power Up | 17 | Device |
| 2023 | Failure to Deliver | 7 | Device |
| 2023 | Failure to Charge | 5 | Device |
| 2023 | Failure to Calibrate | 1 | Device |
| 2023 | Excessive Heating | 13 | Device |
| 2023 | Excess Flow or Over-Infusion | 1 | Device |
| 2023 | Erratic or Intermittent Display | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 13 | Device |
| 2023 | Display Difficult to Read | 8 | Device |
| 2023 | Device Stops Intermittently | 1 | Device |
| 2023 | Device Sensing Problem | 65 | Device |
| 2023 | Device Operates Differently Than Expected | 4 | Device |
| 2023 | Device Inoperable | 2 | Device |
| 2023 | Device Displays Incorrect Message | 3 | Device |
| 2023 | Device Alarm System | 45 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Defective Alarm | 11 | Device |
| 2023 | Decrease in Pressure | 3 | Device |
| 2023 | Date/Time-Related Software Problem | 4 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Computer Software Problem | 1 | Device |
| 2023 | Complete Loss of Power | 5 | Device |
| 2023 | Communication or Transmission Problem | 8 | Device |
| 2023 | Circuit Failure | 3 | Device |
| 2023 | Calibration Problem | 1 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Battery Problem | 20 | Device |
| 2022 | Volume Accuracy Problem | 1 | Device |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unintended Power Up | 5 | Device |
| 2022 | Unexpected Shutdown | 23 | Device |
| 2022 | Self-Activation or Keying | 1 | Device |
| 2022 | Pressure Problem | 8 | Device |
| 2022 | Power Problem | 39 | Device |
| 2022 | Poor Quality Image | 1 | Device |
| 2022 | Partial Blockage | 1 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | No Flow | 4 | Device |
| 2022 | No Display/Image | 14 | Device |
| 2022 | No Audible Alarm | 1 | Device |
| 2022 | Mechanical Problem | 18 | Device |
| 2022 | Mechanical Jam | 4 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Separation | 1 | Device |
| 2022 | Material Integrity Problem | 10 | Device |
| 2022 | Loss of Power | 1 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Intermittent Continuity | 1 | Device |
| 2022 | Insufficient Flow or Under Infusion | 2 | Device |
| 2022 | Infusion or Flow Problem | 6 | Device |
| 2022 | Increase in Pressure | 4 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Inadequate User Interface | 106 | Device |
| 2022 | Inaccurate Flow Rate | 1 | Device |
| 2022 | Inaccurate Delivery | 1 | Device |
| 2022 | Improper Flow or Infusion | 3 | Device |
| 2022 | Human-Device Interface Problem | 1 | Device |
| 2022 | Grounding Malfunction | 1 | Device |
| 2022 | Gas/Air Leak | 14 | Device |
| 2022 | Failure to Shut Off | 3 | Device |
| 2022 | Failure to Run on Battery | 1 | Device |
| 2022 | Failure to Read Input Signal | 2 | Device |
| 2022 | Failure to Power Up | 14 | Device |
| 2022 | Failure to Deliver | 5 | Device |
| 2022 | Failure to Calibrate | 3 | Device |
| 2022 | Failure of Device to Self-Test | 1 | Device |
| 2022 | Excessive Heating | 19 | Device |
| 2022 | Erratic or Intermittent Display | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 6 | Device |
| 2022 | Display or Visual Feedback Problem | 14 | Device |
| 2022 | Display Difficult to Read | 10 | Device |
| 2022 | Device Sensing Problem | 55 | Device |
| 2022 | Device Alarm System | 27 | Device |
| 2022 | Defective Alarm | 14 | Device |
| 2022 | Decrease in Pressure | 1 | Device |
| 2022 | Date/Time-Related Software Problem | 2 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Computer Software Problem | 2 | Device |
| 2022 | Complete Loss of Power | 2 | Device |
| 2022 | Communication or Transmission Problem | 1 | Device |
| 2022 | Circuit Failure | 4 | Device |
| 2022 | Charging Problem | 4 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Blocked Connection | 3 | Device |
| 2022 | Battery Problem | 22 | Device |
| 2021 | Unexpected Shutdown | 1 | Device |
| 2021 | Power Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Unexpected Shutdown | 1 | Device |