TPLC - Total Product Life Cycle

Device	catheter, oximeter, fiberoptic
Regulation Description	Fiberoptic oximeter catheter.
Product Code	DQE
Regulation Number	870.1230
Device Class	2

Device Problems
Measurements, inaccurate	19
Difficult to insert	19
Material frayed	14
Deflation issue	13
Difficult to remove	12
No code available	11
Unraveled material	9
Other (for use when an appropriate device code cannot be identified)	9
Contamination during use	9
Fluid leak	8
Incorrect or inadequate result	8
Break	7
Unknown (for use when the device problem is not known)	7
Foreign material present in device	6
Inflation issue	6
Incorrect measurement	6
No Known Device Problem	5
Low readings	5
Cut in material	4
Material rupture	4
Tip breakage	3
High Readings	3
Device damaged prior to use	3
Difficult to advance	3
Material perforation	2
Sterility	2
Stretched	2
Leak	2
Air leak	2
Balloon rupture	2
Bent	1
Detachment of device component	1
Disconnection	1
Erratic display	1
Knotted	1
Foreign material	1
Tears, rips, holes in device, device material	1
Sticking	1
Tubing, incorrect placement of	1
Twisting	1
Uncoiled	1
Source, detachment from	1
Melted	1
Failure to pace or properly pace	1
Difficult to position	1
Accuracy rate	1
Unable to obtain readings	1
Use of Device Issue	1
Failure to calibrate	1
Detachment of device or device component	1
Positioning Issue	1
Unintended movement	1
Total Device Problems	227