| Device Type ID | 17 |
| Device Name | Compressor, Air, Portable |
| Regulation Description | Portable Air Compressor. |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.6250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTI |
| 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 | 17 |
| Device | Compressor, Air, Portable |
| Product Code | BTI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Portable Air Compressor. |
| CFR Regulation Number | 868.6250 [🔎] |
| Device Problems | |
|---|---|
Device Inoperable | 55 |
Improper Flow Or Infusion | 45 |
Failure To Power Up | 30 |
Product Quality Problem | 19 |
Break | 14 |
No Pressure | 12 |
Device Operates Differently Than Expected | 11 |
Failure To Deliver | 11 |
Electrical /Electronic Property Problem | 6 |
Device Stops Intermittently | 6 |
Device Displays Incorrect Message | 5 |
Pressure Problem | 5 |
Peeled / Delaminated | 5 |
Decrease In Pressure | 5 |
Loss Of Power | 3 |
Noise, Audible | 3 |
No Device Output | 3 |
Device Alarm System | 3 |
Moisture Or Humidity Problem | 2 |
Detachment Of Device Component | 2 |
Degraded | 2 |
Fire | 2 |
Radiation Overexposure | 1 |
Implant Mobility NOS (Not Otherwise Specified) | 1 |
Electronic Property Issue | 1 |
Valve | 1 |
Smoking | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Nebulizer (Only Use When Part Of Another Device) | 1 |
Circuit Failure | 1 |
Arcing | 1 |
Compressor (Air Pump) | 1 |
Device Handling Problem | 1 |
Thermal Decomposition Of Device | 1 |
Overheating Of Device | 1 |
Inaccurate Delivery | 1 |
Delivery System Failure | 1 |
Mechanical Problem | 1 |
Failure To Run On AC/DC | 1 |
| Total Device Problems | 268 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular Us Sales, Llc | II | Jan-28-2014 |