| Device |
system, balloon, intra-aortic and control |
| Regulation Description |
Intra-aortic balloon and control system |
| Product Code | DSP |
| Regulation Number |
870.3535
|
|---|
| Device Class |
3
|
| Device Problems |
| Device-device incompatibility |
628 |
| Device alarm system issue |
246 |
| Fluid leak |
228 |
| Difficult to insert |
127 |
| Component incompatible |
125 |
| Gas leak |
113 |
| Inflation issue |
112 |
| Alarm, audible |
103 |
| Pumping stopped |
94 |
| Low battery |
67 |
| Inadequate user interface |
64 |
| Unable to obtain readings |
63 |
| Kinked |
63 |
| Vacuum, loss of |
61 |
| Leak |
53 |
| Failure to advance |
52 |
| Incorrect display |
45 |
| Other (for use when an appropriate device code cannot be identified) |
41 |
| No display or display failure |
41 |
| Failure to zero |
33 |
| Blood in tubing |
33 |
| Difficult to remove |
26 |
| Not audible alarm |
23 |
| Device operates differently than expected |
22 |
| Material rupture |
22 |
| Occlusion within device |
21 |
| Image display error |
21 |
| Crack |
20 |
| Aspiration issue |
20 |
| Failure to run on AC/DC |
19 |
| Erratic display |
19 |
| Failure to pump |
18 |
| Balloon rupture |
18 |
| Device displays error message |
17 |
| Use of Device Issue |
15 |
| Physical resistance |
13 |
| Misconnection |
12 |
| Low audible alarm |
12 |
| Loose or intermittent connection |
12 |
| Pre or post-pumping problem |
12 |
| Communication or transmission issue |
11 |
| Connection issue |
11 |
| Volume accuracy issue |
10 |
| No device output |
10 |
| Balloon leak(s) |
10 |
| Improper gas output |
8 |
| Difficult to advance |
8 |
| Air leak |
8 |
| Unraveled material |
7 |
| Pumping issue |
7 |
| Failure to sense |
7 |
| Connection error |
7 |
| Failure to calibrate |
6 |
| Loss of power |
6 |
| Fracture |
6 |
| Device sensing issue |
6 |
| Electrical shorting |
5 |
| Component(s), broken |
5 |
| Break |
5 |
| Decoupling |
5 |
| Calibration issue |
5 |
| Material separation |
4 |
| Low readings |
4 |
| Power source issue |
4 |
| Hole in material |
4 |
| Detachment of device or device component |
4 |
| Failure to select signal |
4 |
| Improper or incorrect procedure or method |
4 |
| Difficult to position |
4 |
| Inaccurate synchronization |
4 |
| Output issue |
4 |
| Difficult to interrogate |
4 |
| Battery issue |
3 |
| Device inoperable |
3 |
| Aspiration, incomplete |
3 |
| Difficult to flush |
3 |
| Failure to run on portable mode |
3 |
| Human-Device Interface Issue |
3 |
| Circuit Failure |
3 |
| Entrapment of device or device component |
3 |
| Blank screen |
3 |
| Failure to power-up |
3 |
| Bent |
3 |
| Failure to obtain samples |
3 |
| Electrical issue |
3 |
| Detachment of device component |
2 |
| Calibration error |
2 |
| Intermittent continuity |
2 |
| No Known Device Problem |
2 |
| Failure to deploy |
2 |
| Improper device output |
2 |
| Device stops intermittently |
2 |
| Fitting problem |
2 |
| Tears, rips, holes in device, device material |
2 |
| Material integrity issue |
2 |
| Alarm system, failure of gas-leak/loss |
2 |
| Device contamination with blood or blood product |
2 |
| Augmentation, loss of |
2 |
| Failure to flush |
2 |
| Tube(s), splitting of |
2 |
| Total Device Problems |
3000 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
| Class II |
0 |
2 |
1 |
1 |
0 |
0 |
2 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
