| Device |
monitor, bed patient |
| Regulation Description |
Bed-patient monitor. |
| Product Code | KMI |
| Regulation Number |
880.2400
|
|---|
| Device Class |
1
|
| Device Problems |
| Device alarm system issue |
463 |
| Failure to power-up |
180 |
| Unknown (for use when the device problem is not known) |
147 |
| Alarm, intermittent |
136 |
| Other (for use when an appropriate device code cannot be identified) |
110 |
| Failure to sense |
75 |
| Not audible alarm |
49 |
| False alarm |
34 |
| Loss of power |
30 |
| Failure to reset |
15 |
| Low audible alarm |
9 |
| Corrosion |
8 |
| Wire(s), breakage of |
6 |
| Loose or intermittent connection |
5 |
| Component(s), broken |
5 |
| Display misread |
4 |
| Sensing intermittently |
4 |
| Loose |
3 |
| Use of Device Issue |
3 |
| Low battery |
3 |
| Delayed alarm |
3 |
| Alarm, failure of warning |
3 |
| Sensor problems |
2 |
| Protective measure issue |
2 |
| Volume accuracy issue |
2 |
| Cable, defective |
2 |
| Defective Alarm |
2 |
| Battery failure |
2 |
| Break |
2 |
| Function indicator light(s), failure of |
2 |
| Detachment of device component |
2 |
| Continuous |
2 |
| Shock, electrical |
1 |
| Fail-safe design failure |
1 |
| Device stops intermittently |
1 |
| Crack |
1 |
| No display or display failure |
1 |
| Incorrect display |
1 |
| Potentiometer readings, high |
1 |
| Circuit Failure |
1 |
| Failure, intermittent |
1 |
| Pressure sensor failure |
1 |
| Close, difficult to |
1 |
| Electrical wires, defective |
1 |
| Precision |
1 |
| Failure to deploy |
1 |
| Total Device Problems |
1329 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
1 |
1 |
2 |
1 |
3 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
