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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
2021 7 7
2022 8 9
2023 8 8
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver Shock/Stimulation 3 3
Arcing of Electrodes 3 3
Sparking 3 4
Insufficient Information 3 3
Failure to Sense 2 2
Device Emits Odor 2 3
Fire 2 2
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Melted 1 1
Overheating of Device 1 1
Unable to Obtain Readings 1 1
Electrical /Electronic Property Problem 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Burn(s) 4 4
Insufficient Information 4 4
Superficial (First Degree) Burn 3 4
Blister 2 2
Cardiac Arrest 2 2
Erythema 2 2
Shock from Patient Lead(s) 1 1
Respiratory Arrest 1 1
Abrasion 1 2
Atrial Fibrillation 1 1
Itching Sensation 1 1
Rash 1 1
Cardiopulmonary Arrest 1 1
Skin Tears 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Bruise/Contusion 1 1
Skin Burning Sensation 1 1

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