| Device Type ID | 225 |
| Device Name | Ventilator, High Frequency |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LSZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 225 |
| Device | Ventilator, High Frequency |
| Product Code | LSZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 97 |
Failure To Cycle | 29 |
Device Stops Intermittently | 29 |
Device Inoperable | 22 |
Mechanical Problem | 21 |
Inaccurate Delivery | 17 |
No Audible Alarm | 15 |
Pressure Problem | 12 |
Decrease In Pressure | 7 |
Overheating Of Device | 7 |
Noise, Audible | 7 |
Device Displays Incorrect Message | 7 |
Calibration Problem | 5 |
Defective Alarm | 5 |
Out-Of-Box Failure | 5 |
Temperature Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Appropriate Term/Code Not Available | 4 |
Smoking | 3 |
Overfill | 3 |
Insufficient Heating | 3 |
False Alarm | 3 |
Alarm Not Visible | 3 |
Failure To Power Up | 2 |
Microbial Contamination Of Device | 2 |
Moisture Damage | 2 |
Moisture Or Humidity Problem | 2 |
Calibration Error | 2 |
Device Alarm System | 2 |
Low Readings | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Inaccurate Flow Rate | 1 |
Unexpected Therapeutic Results | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Increase In Pressure | 1 |
Device Difficult To Program Or Calibrate | 1 |
Electromagnetic Compatibility Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Failure To Calibrate | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
No Display / Image | 1 |
Melted | 1 |
Disconnection | 1 |
Restricted Flow Rate | 1 |
Loose Or Intermittent Connection | 1 |
Thermal Decomposition Of Device | 1 |
Display Or Visual Feedback Problem | 1 |
Fluid Leak | 1 |
Improper Flow Or Infusion | 1 |
Blocked Connection | 1 |
Off-Label Use | 1 |
Misassembly By Users | 1 |
Unexpected Shutdown | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
Improper Alarm | 1 |
| Total Device Problems | 353 |