| Device Type ID | 67 |
| Device Name | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Regulation Description | Breathing System Heater. |
| 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 | 868.5270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BZE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 67 |
| Device | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Product Code | BZE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breathing System Heater. |
| CFR Regulation Number | 868.5270 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FISHER & PAYKEL HEALTHCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FLEXICARE MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PLASTIFLEX GROUP NV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESPIRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Crack | 174 |
Insufficient Heating | 108 |
Temperature Problem | 92 |
Leak / Splash | 47 |
Device Issue | 34 |
Connection Problem | 22 |
Disconnection | 17 |
Moisture Or Humidity Problem | 13 |
Air Leak | 12 |
Power Problem | 12 |
Device Operates Differently Than Expected | 10 |
Break | 10 |
Breathing Circuit | 9 |
Cut In Material | 8 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Y-Piece Connector | 7 |
Hole In Material | 7 |
Failure To Power Up | 6 |
Device Handling Problem | 5 |
Insufficient Information | 5 |
Loose Or Intermittent Connection | 5 |
Overheating Of Device | 4 |
Material Perforation | 4 |
Material Integrity Problem | 4 |
Gas Leak | 4 |
Melted | 4 |
Use Of Device Problem | 4 |
Material Puncture / Hole | 3 |
Physical Property Issue | 3 |
Split | 3 |
Detachment Of Device Or Device Component | 2 |
Material Separation | 2 |
Increase In Pressure | 2 |
Circuit Failure | 2 |
Device Operational Issue | 2 |
Changes In Ambient Temperature In Device Environment | 1 |
Fracture | 1 |
Sparking | 1 |
Human-Device Interface Problem | 1 |
Material Discolored | 1 |
Device Inoperable | 1 |
Ambient Temperature Problem | 1 |
Latch | 1 |
Ventilation Problem In Device Environment | 1 |
No Apparent Adverse Event | 1 |
Degraded | 1 |
Smoking | 1 |
Failure To Deliver | 1 |
Device Emits Odor | 1 |
Patient Device Interaction Problem | 1 |
Intermittent Loss Of Power | 1 |
Mechanical Jam | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Temperature Probe | 1 |
Detachment Of Device Component | 1 |
Charred | 1 |
Mechanical Problem | 1 |
Torn Material | 1 |
Device Damaged Prior To Use | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Mechanics Altered | 1 |
Connector | 1 |
Defective Alarm | 1 |
Thermal Decomposition Of Device | 1 |
| Total Device Problems | 684 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Carefusion 2200 Inc | II | Sep-23-2014 |