Definition: Computer Assisted System To Administer A Drug And Control Depth Of Sedation And Provide Monitoring And Alarms For Physiological Vital Signs And Other Parameters Of Sedation.
| Device Type ID | 232 |
| Device Name | Computer-assisted Personalized Sedation System |
| Physical State | Computer Controlled Infusion Pump, Multi-parameter Physiological Monitoring, Negative Feedback Control System Algorithm. |
| Technical Method | Computer Assisted Drug Administration Using Feedback From Patient Physiological Parameters. |
| Target Area | Central Nervous System, Cardiopulmonary System. |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PDR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 232 |
| Device | Computer-assisted Personalized Sedation System |
| Product Code | PDR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon Endo-Surgery Inc | I | Aug-26-2015 |