| Device |
ventilator, high frequency |
| Product Code | LSZ |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
|
1
|
0
|
0
|
1
|
0
|
1
|
3
|
2
|
4
|
3
|
1
|
|
| Device Problems |
| Not audible alarm |
76 |
| Device inoperable |
51 |
| Failure to cycle |
49 |
| Decrease in pressure |
33 |
| Inaccurate delivery |
22 |
| Device alarm system issue |
21 |
| Device operates differently than expected |
9 |
| Other (for use when an appropriate device code cannot be identified) |
9 |
| Increase in pressure |
8 |
| No code available |
7 |
| Out-of-box failure |
6 |
| Pressure issue |
5 |
| Device displays error message |
5 |
| Calibration issue |
5 |
| Defective Alarm |
5 |
| Noise, Audible |
5 |
| Shock, electrical |
4 |
| Failure to calibrate |
4 |
| Connection error |
4 |
| Overheating of device or device component |
3 |
| Smoking |
3 |
| Low readings |
3 |
| Overfill |
3 |
| Output, high |
3 |
| Alarm, intermittent |
3 |
| False alarm |
3 |
| Alarm not visible |
3 |
| Calibration error |
2 |
| Detachment of device component |
2 |
| Alarm, audible |
2 |
| Output, low |
2 |
| Melted |
2 |
| Moisture damage |
2 |
| Incorrect display |
2 |
| Loose or intermittent connection |
2 |
| Disconnection |
2 |
| Erratic display |
2 |
| Moisture or humidity problem |
2 |
| No Known Device Problem |
2 |
| Temperature issue |
1 |
| Misassembled by Users |
1 |
| Electromagnetic compatibility issue |
1 |
| Human-Device Interface Issue |
1 |
| Improper flow or infusion |
1 |
| Maintenance does not comply to manufacturers recommendations |
1 |
| Spark |
1 |
| Blocked connection |
1 |
| Alarm, failure of high inspiratory pressure |
1 |
| Device stops intermittently |
1 |
| Alarm system, failure of gas-leak/loss |
1 |
| Tears, rips, holes in device, device material |
1 |
| Unexpected therapeutic results |
1 |
| User used incorrect product for intended use |
1 |
| Difficult to Program or Calibrate |
1 |
| Loss of power |
1 |
| Failure to power-up |
1 |
| Improper or incorrect procedure or method |
1 |
| Noise |
1 |
| Unknown (for use when the device problem is not known) |
1 |
| Defective component |
1 |
| No display or display failure |
1 |
| Electrical issue |
1 |
| Explode |
1 |
| Filter |
1 |
| Improper gas output |
1 |
| Head immobilizer failure |
1 |
| Leak |
1 |
| Device maintenance issue |
1 |
| Electro-magnetic interference (EMI) |
1 |
| Delayed alarm |
1 |
| Failure to run on AC/DC |
1 |
| Air leak |
1 |
| Component(s), overheating of |
1 |
| Circuit Failure |
1 |
| Component(s), broken |
1 |
| Alarm, failure of warning |
1 |
| Break |
1 |
| Total Device Problems |
414 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
| Class I |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
