| Device |
humidifier, respiratory gas, (direct patient interface) |
| Regulation Description |
Respiratory gas humidifier. |
| Product Code | BTT |
| Regulation Number |
868.5450
|
|---|
| Device Class |
2
|
| Device Problems |
| Leak |
39 |
| Detachment of device component |
34 |
| Other (for use when an appropriate device code cannot be identified) |
33 |
| Burn of device or device component |
20 |
| Component missing |
18 |
| Overheating of device or device component |
15 |
| Crack |
14 |
| Disconnection |
14 |
| Break |
13 |
| Circuit Failure |
12 |
| Fluid leak |
11 |
| Melted |
11 |
| Overfill |
11 |
| Air leak |
11 |
| Corrosion |
10 |
| Insufficient heating |
9 |
| Defective item |
9 |
| Not audible alarm |
9 |
| Material separation |
8 |
| Device Issue |
8 |
| Connection issue |
8 |
| Tear, rip or hole in device packaging |
8 |
| Device displays error message |
7 |
| Bent |
7 |
| Device operates differently than expected |
6 |
| Artifact |
5 |
| Temperature issue |
5 |
| Use of Device Issue |
4 |
| Heat |
4 |
| Mechanical issue |
4 |
| Device emits odor |
4 |
| Moisture or humidity problem |
4 |
| Threader failure |
4 |
| Device alarm system issue |
3 |
| Moisture damage |
3 |
| Alarm not visible |
3 |
| Fire |
3 |
| Component(s), broken |
3 |
| Split |
3 |
| Output, low |
2 |
| Smoking |
2 |
| Failure to deliver |
2 |
| Filter |
2 |
| Sterility |
2 |
| Burst |
2 |
| Incomplete or missing packaging |
2 |
| Blockage within device or device component |
2 |
| Component(s), overheating of |
2 |
| Fitting problem |
2 |
| Device Contamination with biological material |
2 |
| Material deformation |
2 |
| Occlusion within device |
2 |
| Malfunction |
2 |
| No Known Device Problem |
1 |
| Defective Alarm |
1 |
| Calibration error |
1 |
| Measurements, inaccurate |
1 |
| Insufficient flow or underinfusion |
1 |
| Device damaged prior to use |
1 |
| Valve(s), defective |
1 |
| Loose or intermittent connection |
1 |
| Misassembled |
1 |
| Restricted flowrate |
1 |
| Pressure issue |
1 |
| Electronic property issue |
1 |
| Tube(s), defective |
1 |
| Sharp/jagged/rough/etched/scratched |
1 |
| Material discolored |
1 |
| Function indicator light(s), failure of |
1 |
| Gas delivery system failure |
1 |
| Loose |
1 |
| Output energy incorrect |
1 |
| Port leak(s) |
1 |
| Sticking |
1 |
| Improper or incorrect procedure or method |
1 |
| False reading from device non-compliance |
1 |
| Misassembled by Users |
1 |
| Spark |
1 |
| Tears, rips, holes in device, device material |
1 |
| Noise |
1 |
| Temperature probe, loose |
1 |
| Material opacification |
1 |
| Loss of power |
1 |
| Sensor problems |
1 |
| Alarm, failure of warning |
1 |
| Material fragmentation |
1 |
| Interference with monitoring device |
1 |
| Method, improper/incorrect |
1 |
| Migration of device or device component |
1 |
| Instruction for use issue |
1 |
| Connection error |
1 |
| Filling problem |
1 |
| Low audible alarm |
1 |
| Burn hole(s) |
1 |
| Stretched |
1 |
| Cut in material |
1 |
| Torn material |
1 |
| No code available |
1 |
| Improper flow or infusion |
1 |
| Packaging issue |
1 |
| Total Device Problems |
472 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
| Class II |
2 |
1 |
0 |
1 |
1 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
