Definition: Indicated For Use In Full-term Infants With Clinical Evidence Of Moderate To Severe Hypoxic-ischemic Encephalopathy (HIE)*. Provides Selective Head Cooling With Mild Systemic Hypothermia To Prevent Or Reduce The Severity Of Neurologic Injury Associat
| Device Type ID | 3849 |
| Device Name | Cap, Cooling (infants) |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MXM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3849 |
| Device | Cap, Cooling (infants) |
| Product Code | MXM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Use Of Device Problem | 7 |
Insufficient Cooling | 6 |
Device Displays Incorrect Message | 5 |
Fluid Leak | 5 |
No Display / Image | 4 |
Device Operates Differently Than Expected | 4 |
Device Stops Intermittently | 3 |
Power Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Unexpected Shutdown | 2 |
Inability To Auto-Fill | 1 |
Mechanical Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Connector | 1 |
No Flow | 1 |
Cap | 1 |
Fracture | 1 |
| Total Device Problems | 47 |