TPLC - Total Product Life Cycle

Device	electrode, electrodcardiograph, multi-function
Regulation Description	Electrocardiograph electrode.
Product Code	MLN
Regulation Number	870.2360
Device Class	2

Device Problems
Failure to shock or properly shock	18
Failure to capture	13
Unknown (for use when the device problem is not known)	9
Device operates differently than expected	9
Spark	7
Connection issue	7
No Known Device Problem	7
Failure to deliver energy	7
Device damaged prior to use	5
Failure to deliver	4
Burn of device or device component	4
No Information	4
Arcing	4
Device sensing issue	3
Therapeutic or diagnostic output failure	3
Not Applicable	3
Break	3
Electrode(s), failure of	3
No device output	3
Failure to analyze rhythm	3
Failure to sense	3
Sticking	2
Electrode contact(s), problem with	2
Fire	2
Gel leak	2
Misconnection	2
Bent	2
Detachment of device component	2
Other (for use when an appropriate device code cannot be identified)	2
Device displays error message	2
Device inoperable	2
Use of Device Issue	1
Difficult to open or remove packaging material	1
Failure of device to self-test	1
Device handling issue	1
Connection error	1
Connector pin failure	1
Couple, failure to	1
Failure to deploy	1
Failure to discharge	1
Intermittent capture	1
Material frayed	1
Electrode(s), fracture of	1
Failure to charge	1
Inadequate storage	1
Slippage of device or device component	1
Failure to pace or properly pace	1
Unable to obtain readings	1
Wire(s), breakage of	1
Failure to separate	1
Difficult or delayed activation	1
Arcing at electrodes	1
Defective component	1
Total Device Problems	164