Definition: This Product Code Was Needed For The Home Use Indication. CBK Is Not A Tracked Device And NOU Is A Tracked Device.
| Device Type ID | 166 |
| Device Name | Continuous, Ventilator, Home 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 | NOU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 166 |
| Device | Continuous, Ventilator, Home Use |
| Product Code | NOU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Ventilator. |
| CFR Regulation Number | 868.5895 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Calibrate | 952 |
Device Displays Incorrect Message | 860 |
Power Problem | 213 |
Battery Problem | 197 |
Inappropriate Or Unexpected Reset | 128 |
No Display / Image | 111 |
Device Inoperable | 106 |
Charging Problem | 90 |
Device Stops Intermittently | 81 |
Pressure Problem | 28 |
Failure To Power Up | 27 |
Device Alarm System | 25 |
Failure To Charge | 25 |
Device Sensing Problem | 17 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Device Operational Issue | 10 |
Device Operates Differently Than Expected | 8 |
Appropriate Term/Code Not Available | 8 |
Failure To Run On AC/DC | 8 |
Low Battery | 6 |
Communication Or Transmission Problem | 6 |
Battery | 5 |
No Audible Alarm | 5 |
Calibration Problem | 5 |
Temperature Problem | 4 |
Loss Of Power | 4 |
No Flow | 4 |
Insufficient Heating | 4 |
Blower | 3 |
Switch, Push Button | 3 |
Volume Accuracy Problem | 2 |
Insufficient Information | 2 |
Failure To Shut Off | 2 |
Failure To Discharge | 2 |
Protective Measures Problem | 2 |
Keyboard | 2 |
Alarm Not Visible | 2 |
Detachment Of Device Component | 2 |
Image Display Error / Artifact | 2 |
Decrease In Pressure | 2 |
Improper Alarm | 2 |
Failure To Cycle | 2 |
Fracture | 2 |
Circuit Failure | 2 |
Insufficient Cooling | 2 |
Material Frayed | 2 |
Increase In Pressure | 2 |
Use Of Device Problem | 2 |
Failure To Deliver | 2 |
Incorrect Measurement | 1 |
Melted | 1 |
Device Difficult To Program Or Calibrate | 1 |
Failure To Run On Battery | 1 |
Premature Discharge Of Battery | 1 |
Keypad | 1 |
Infusion Or Flow Problem | 1 |
Battery Charger | 1 |
Power Module | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Data Problem | 1 |
No Pressure | 1 |
Failure Of Device To Self-Test | 1 |
Leak / Splash | 1 |
Fail-Safe Design Failure | 1 |
Cooling Module | 1 |
Lithium Iodide Battery | 1 |
Delayed Alarm | 1 |
Device Issue | 1 |
Display Or Visual Feedback Problem | 1 |
Pumping Stopped | 1 |
Crack | 1 |
Output Problem | 1 |
Noise, Audible | 1 |
Display | 1 |
Calibration Error | 1 |
| Total Device Problems | 3019 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Breas Medical AB | II | Jul-16-2015 |
| 2 | Human Design Medical Llc | III | Jul-23-2018 |