| Device |
transducer, blood-pressure, extravascular |
| Regulation Description |
Extravascular blood pressure transducer. |
| Product Code | DRS |
| Regulation Number |
870.2850
|
|---|
| Device Class |
2
|
| Device Problems |
| Detachment of device component |
190 |
| Leak |
142 |
| Break |
100 |
| Contamination during use |
46 |
| Fluid leak |
37 |
| Crack |
33 |
| Component(s), broken |
30 |
| Drift |
30 |
| Tube(s), buckling of |
29 |
| Air leak |
20 |
| Measurements, inaccurate |
19 |
| Material separation |
18 |
| Disconnection |
14 |
| Unknown (for use when the device problem is not known) |
13 |
| Cut in material |
11 |
| Source, leak(s) from |
11 |
| Inaccurate flowrate |
11 |
| Incorrect measurement |
9 |
| Defective item |
6 |
| False device output |
6 |
| Tears, rips, holes in device, device material |
6 |
| Transducer failure |
6 |
| Hole in material |
6 |
| Failure to flush |
5 |
| Source, detachment from |
5 |
| Loose or intermittent connection |
5 |
| Unable to obtain readings |
5 |
| Wavelength, incorrect |
5 |
| High Readings |
5 |
| Bleed back |
4 |
| Use of Device Issue |
4 |
| Other (for use when an appropriate device code cannot be identified) |
4 |
| Device Issue |
4 |
| False reading from device non-compliance |
4 |
| Defective component |
4 |
| Tube(s), defective |
4 |
| Sticking |
4 |
| Failure to zero |
3 |
| Blockage within device or device component |
3 |
| Foreign material |
3 |
| Unsealed device packaging |
3 |
| Stopcock valve, failure of |
3 |
| Particulates |
3 |
| Incorrect or inadequate result |
3 |
| Misassembled |
3 |
| Delivered as unsterile product |
3 |
| Kinked |
3 |
| Device damaged prior to use |
2 |
| Valve(s), defective |
2 |
| Blood pooling |
2 |
| Occlusion within device |
2 |
| Pressure sensor failure |
2 |
| Electrical issue |
2 |
| Disassembly |
2 |
| Colony forming units |
2 |
| Obstruction within device |
2 |
| Tubing, incorrect placement of |
2 |
| Bubble(s) |
2 |
| Fitting problem |
2 |
| Valve(s), failure of |
1 |
| Loose |
1 |
| Failure to read input signal |
1 |
| Decoupling |
1 |
| Material discolored |
1 |
| Dislodged |
1 |
| Inadequate filtration process |
1 |
| Device contamination with blood or blood product |
1 |
| Solder joint failure |
1 |
| Overdelivery |
1 |
| Low readings |
1 |
| Foreign material present in device |
1 |
| Pressure issue |
1 |
| Loss of power |
1 |
| Failure to prime |
1 |
| Accuracy rate |
1 |
| Blood in tubing |
1 |
| Out-of-box failure |
1 |
| Fracture |
1 |
| Burst |
1 |
| Design/structure problem |
1 |
| Device operates differently than expected |
1 |
| Excess flow or overinfusion |
1 |
| Detachment of device or device component |
1 |
| Improper flow or infusion |
1 |
| Output issue |
1 |
| Not Applicable |
1 |
| Incorrect or inadequate test results |
1 |
| Material perforation |
1 |
| Abnormal |
1 |
| Compatibility |
1 |
| Connector pin failure |
1 |
| Difficult to flush |
1 |
| Tube(s), splitting of |
1 |
| Lens replacement |
1 |
| Failure to reset |
1 |
| Torqued |
1 |
| Valve(s), sticking |
1 |
| Increase in pressure |
1 |
| Erratic display |
1 |
| Biofilm coating in device |
1 |
| Total Device Problems |
950 |
|
|
|
