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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

Device Problems
Failure to shock or properly shock 17
Failure to capture 13
Unknown (for use when the device problem is not known) 9
Spark 7
Connection issue 6
Failure to deliver energy 6
Device damaged prior to use 5
No Known Device Problem 5
No Information 4
Device operates differently than expected 4
Arcing 4
Failure to deliver 4
Burn of device or device component 4
Break 3
No device output 3
Electrode(s), failure of 3
Failure to analyze rhythm 3
Failure to sense 3
Device sensing issue 3
Therapeutic or diagnostic output failure 3
Not Applicable 3
Misconnection 2
Other (for use when an appropriate device code cannot be identified) 2
Sticking 2
Electrode contact(s), problem with 2
Fire 2
Bent 2
Detachment of device component 2
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
Failure to pace or properly pace 1
Unable to obtain readings 1
Electrode(s), fracture of 1
Failure to charge 1
Inadequate storage 1
Device inoperable 1
Use of Device Issue 1
Slippage of device or device component 1
Wire(s), breakage of 1
Failure to separate 1
Difficult or delayed activation 1
Arcing at electrodes 1
Defective component 1
Device displays error message 1
Difficult to open or remove packaging material 1
Device handling issue 1
Total Device Problems 149

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 0 2 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Sep-20-2008
2 ConMed Corporation II Jan-25-2012
3 Conmed Corporation II Apr-24-2007
4 Heart Sync, Inc II Apr-12-2011
5 Heart Sync, Inc II Feb-18-2011

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