| Device Type ID | 3629 |
| Device Name | System, Hypothermia, Intravenous, Cooling |
| Regulation Description | Thermal Regulating System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3629 |
| Device | System, Hypothermia, Intravenous, Cooling |
| Product Code | NCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal Regulating System. |
| CFR Regulation Number | 870.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ZOLL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SE - WITH LIMITATIONS | 2 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 489 |
Device Displays Incorrect Message | 398 |
Visual Prompts Will Not Clear | 291 |
Leak / Splash | 221 |
Device Issue | 139 |
Use Of Device Problem | 125 |
Adverse Event Without Identified Device Or Use Problem | 83 |
Device Operational Issue | 52 |
No Display / Image | 17 |
Failure To Power Up | 17 |
Fluid Leak | 16 |
Insufficient Cooling | 16 |
Temperature Problem | 12 |
Insufficient Heating | 8 |
Loss Of Power | 6 |
Difficult To Insert | 5 |
Difficult To Remove | 4 |
Device Stops Intermittently | 4 |
Device Inoperable | 4 |
Loose Or Intermittent Connection | 3 |
Device Alarm System | 3 |
Display Or Visual Feedback Problem | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Power Problem | 2 |
Catheter | 2 |
Degraded | 1 |
Activation, Positioning Or Separation Problem | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Difficult Or Delayed Positioning | 1 |
Electrical /Electronic Property Problem | 1 |
Electrical Power Problem | 1 |
Fan | 1 |
Excessive Cooling | 1 |
Output Problem | 1 |
Display | 1 |
Break | 1 |
Insufficient Flow Or Under Infusion | 1 |
Positioning Problem | 1 |
Kinked | 1 |
Pump | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Protective Measures Problem | 1 |
Intermittent Loss Of Power | 1 |
| Total Device Problems | 1941 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Healthcare | II | Jan-27-2014 |