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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2017 19 19
2018 14 14
2019 11 11
2020 1 1
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 6 6
Device Sensing Problem 6 6
Failure to Sense 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Failure of Device to Self-Test 5 5
Connection Problem 4 4
Appropriate Term/Code Not Available 4 4
Insufficient Information 3 3
Bent 2 2
Break 1 1
Failure to Deliver Shock/Stimulation 1 1
Failure to Discharge 1 1
Failure to Deliver Energy 1 1
Gel Leak 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Failure to Analyze Signal 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Arcing of Electrodes 1 1
Incomplete or Missing Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
No Patient Involvement 4 4
Skin Tears 4 4
No Information 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Death 2 2
Superficial (First Degree) Burn 2 2
Burn(s) 2 2
Cardiac Arrest 1 1
Burn, Thermal 1 1
No Code Available 1 1

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