Definition: A Non Self-inflating Manual Resuscitator, Also Called A Hyperinflation System, Is A Manual Ventilator Intended To Ventilate A Patient By Forcing A Volume Of Fresh Gas Into The Patient Via Compression Of The Ventilator Bag; A Source Of Compressed Brea
| Device Type ID | 158 |
| Device Name | Resuscitator, Manual, Non Self-inflating |
| Regulation Description | Noncontinuous Ventilator (IPPB). |
| 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 | 868.5905 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 158 |
| Device | Resuscitator, Manual, Non Self-inflating |
| Product Code | NHK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Noncontinuous Ventilator (IPPB). |
| CFR Regulation Number | 868.5905 [🔎] |
| Device Problems | |
|---|---|
Device Damaged Prior To Use | 17 |
Loose Or Intermittent Connection | 12 |
Defective Component | 5 |
Device Operates Differently Than Expected | 5 |
Infusion Or Flow Problem | 3 |
Fracture | 2 |
Bags | 2 |
Material Perforation | 2 |
Air Leak | 2 |
Leak / Splash | 1 |
Decrease In Pressure | 1 |
Split | 1 |
Break | 1 |
Connector | 1 |
Material Puncture / Hole | 1 |
Inflation Problem | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Valve, PEEP (Positive End Expiratory Pressure) | 1 |
Decoupling | 1 |
Product Quality Problem | 1 |
| Total Device Problems | 61 |