| Device |
tube tracheostomy and tube cuff |
| Regulation Description |
Tracheostomy tube and tube cuff. |
| Product Code | JOH |
| Regulation Number |
868.5800
|
|---|
| Device Class |
2
|
| Device Problems |
| Air leak |
555 |
| Detachment of device component |
76 |
| Tears, rips, holes in device, device material |
59 |
| Fitting problem |
49 |
| Break |
42 |
| Fluid leak |
34 |
| Difficult to remove |
25 |
| Unknown (for use when the device problem is not known) |
20 |
| Deflation, cause unknown |
19 |
| Device Issue |
18 |
| Defective item |
12 |
| Leak |
12 |
| Replace |
11 |
| Other (for use when an appropriate device code cannot be identified) |
10 |
| Component(s), broken |
10 |
| Balloon leak(s) |
10 |
| Sharp/jagged/rough/etched/scratched |
8 |
| Alarm, audible |
6 |
| Hose line occlusion |
5 |
| Interference |
5 |
| Wire(s), breakage of |
5 |
| Deflation issue |
5 |
| Deflation due to trauma |
5 |
| Use of Device Issue |
4 |
| Component incompatible |
4 |
| Dislodged |
4 |
| Shaft, split |
4 |
| Occlusion within device |
4 |
| Disconnection |
3 |
| Displacement |
3 |
| Size incorrect for patient |
3 |
| Material separation |
3 |
| Balloon rupture |
3 |
| Balloon burst |
2 |
| Loss of or failure to bond |
2 |
| No code available |
2 |
| Device operates differently than expected |
2 |
| Method, improper/incorrect |
2 |
| Occlusion, incorrect |
2 |
| Device, removal of (non-implant) |
2 |
| Difficult to insert |
2 |
| Kinked |
2 |
| Material rupture |
2 |
| Malfunction |
2 |
| Failure to disconnect |
2 |
| Device markings issue |
1 |
| No Known Device Problem |
1 |
| Volume accuracy issue |
1 |
| Balloon mushroomed |
1 |
| Coiled |
1 |
| Restricted flowrate |
1 |
| Device-device incompatibility |
1 |
| Blockage within device or device component |
1 |
| Valve(s), failure of |
1 |
| Improper or incorrect procedure or method |
1 |
| Misapplication |
1 |
| Misconnection |
1 |
| Inflation issue |
1 |
| Failure to deploy |
1 |
| Foreign material |
1 |
| Infusion or flow issue |
1 |
| Tube(s), buckling of |
1 |
| Inadequate user interface |
1 |
| No Information |
1 |
| Obstruction within device |
1 |
| Cut in material |
1 |
| Crack |
1 |
| Suction issue |
1 |
| Installation error |
1 |
| Mislabeled |
1 |
| Nonstandard device or device component |
1 |
| Increase in suction |
1 |
| Total Device Problems |
1087 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
1 |
2 |
0 |
1 |
0 |
| Class II |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
