Definition: Intended For Use As A CPR Adjunct To Improve The Likelihood Of Survival In Adult Patients With Non-traumatic Cardiac Arrest.
| Device Type ID | 1080 |
| Device Name | Combination Compression/decompression Manual Chest Pump With Impedance Respiratory Valve |
| Physical State | The Device System Is Comprised Of Two Components: A Manual Pump Containing A Suction Cup So That Active Decompression Can Take Place. The Valve Is Inserted In The Respiratory Circuit (e.g., Facemask Or Advanced Airway) During CPR. |
| Technical Method | Uses Active Compression And Decompression Of The Victim's Chest During Manual CPR, As Well As Impeding The Inflow Of Air During The Decompression Phase To Reduce The Intrathoracic Pressure And Increase Blood Flow. |
| Target Area | The Pump Is Placed On The Victim's Chest, And The Valve Is Placed Within The Respiratory Circuit. |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PIZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1080 |
| Device | Combination Compression/decompression Manual Chest Pump With Impedance Respiratory Valve |
| Product Code | PIZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 9 |
Misassembled | 7 |
Detachment Of Device Or Device Component | 5 |
Mechanical Problem | 4 |
Detachment Of Device Component | 4 |
Calibration Problem | 2 |
Device Operational Issue | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 33 |