| Device Type ID | 149 |
| Device Name | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Regulation Description | Continuous Ventilator. |
| Regulation Medical Specialty | Anesthesiology |
| 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 | 510(k) |
| CFR Regulation Number | 868.5895 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MNT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 149 |
| Device | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Product Code | MNT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Ventilator. |
| CFR Regulation Number | 868.5895 [🔎] |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 194 |
Device Operates Differently Than Expected | 158 |
Device Inoperable | 97 |
Failure To Power Up | 51 |
Alarm, Audible | 44 |
Loss Of Power | 36 |
Device Alarm System | 29 |
Data Acquisition Unit | 28 |
Battery Problem | 25 |
No Display / Image | 23 |
Pressure Sensor | 21 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Pressure Problem | 17 |
Sensor | 17 |
Battery | 15 |
Power Problem | 12 |
Failure To Charge | 12 |
No Flow | 11 |
Temperature Problem | 11 |
Leak / Splash | 11 |
Device Operational Issue | 10 |
Failure To Sense | 10 |
Failure Of Device To Self-Test | 9 |
Device Issue | 8 |
Screen | 8 |
Display | 6 |
Failure To Run On AC/DC | 5 |
Break | 5 |
Mechanical Problem | 5 |
Device Emits Odor | 5 |
Electrical /Electronic Property Problem | 5 |
Data Problem | 5 |
Blower | 5 |
Device Stops Intermittently | 4 |
Device Sensing Problem | 4 |
Appropriate Term/Code Not Available | 4 |
No Audible Alarm | 4 |
Device Handling Problem | 4 |
Overheating Of Device | 4 |
Calibration Problem | 3 |
Calibration Error | 3 |
Unexpected Shutdown | 3 |
Occlusion Within Device | 3 |
Unit | 3 |
Material Discolored | 3 |
Charging Problem | 3 |
PC (Printed Circuit) Board | 3 |
Infusion Or Flow Problem | 3 |
Fire | 2 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 2 |
Increase In Pressure | 2 |
Premature Discharge Of Battery | 2 |
Circuit Failure | 2 |
Smoking | 2 |
Physical Property Issue | 2 |
Gas Output Problem | 2 |
Use Of Incorrect Control Settings | 2 |
Volume Accuracy Problem | 2 |
Mechanics Altered | 2 |
Delivery System Failure | 2 |
Output Problem | 2 |
Display Or Visual Feedback Problem | 2 |
No Device Output | 1 |
Low Audible Alarm | 1 |
Discrete Component/Device (Resistor, Capacitor, Diode) | 1 |
Controller | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Disconnection | 1 |
Defective Alarm | 1 |
Alarm | 1 |
Alarm, Oxygen Pressure | 1 |
CPU (Central Processing Unit) Board | 1 |
False Negative Result | 1 |
Excess Flow Or Over-Infusion | 1 |
Breathing Circuit | 1 |
Air Leak | 1 |
Under-Sensing | 1 |
Out-Of-Box Failure | 1 |
Intermittent Loss Of Power | 1 |
Misassembly By Users | 1 |
Improper Alarm | 1 |
No Pressure | 1 |
Alarm Not Visible | 1 |
Poor Quality Image | 1 |
Unintended Collision | 1 |
Decrease In Pressure | 1 |
Reset Problem | 1 |
Device Subassembly | 1 |
Failure To Pump | 1 |
Tidal Volume Fluctuations | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Failure To Calibrate | 1 |
Manifold | 1 |
Insufficient Cooling | 1 |
Connection Problem | 1 |
Gauges/Meters | 1 |
| Total Device Problems | 1036 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Respironics California Inc | I | May-18-2017 |
| 2 | Respironics California Inc | II | Mar-27-2017 |