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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrocardiograph
Regulation Description Electrocardiograph electrode.
Product CodeDRX
Regulation Number 870.2360
Device Class 2

MDR Year MDR Reports MDR Events
2019 50 50
2020 53 54
2021 55 57
2022 61 62
2023 113 114
2024 61 61
2025 250 250
2026 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 215 215
Biocompatibility 176 176
Insufficient Device Problem Information 87 87
Connection Problem 39 39
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Device Sensing Problem 13 13
Fitting Problem 12 12
Patient-Device Incompatibility 11 11
Patient Device Interaction Problem 10 10
Use of Device Problem 10 10
Failure to Deliver Shock/Stimulation 8 8
Appropriate Device Problem Term/Code Not Available 7 7
Incorrect Interpretation of Signal 7 7
Loose or Intermittent Connection 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Product Quality Problem 4 4
Disconnection 4 4
Improper or Incorrect Procedure or Method 4 4
Overheating of Device 4 4
Electrical /Electronic Property Problem 3 3
Mechanical Problem 3 3
Failure to Read Input Signal 3 3
Loss of or Failure to Bond 3 3
Defective Component 3 4
Device Handling Problem 2 2
Failure to Transmit Record 2 2
Defibrillation/Stimulation Problem 2 2
Material Integrity Problem 2 2
No Apparent Adverse Event 2 2
Image Display Error/Artifact 1 2
Unintended Electrical Shock 1 1
Temperature Problem 1 1
Electrical Power Problem 1 1
Failure to Deliver Energy 1 1
Device Appears to Trigger Rejection 1 1
Pacing Problem 1 1
Device Dislodged or Dislocated 1 1
Peeled/Delaminated 1 1
Activation, Positioning or Separation Problem 1 1
Separation Problem 1 1
Material Too Rigid or Stiff 1 1
Failure to Analyze Signal 1 1
Unintended Movement 1 1
Unable to Obtain Readings 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 345 345
No Clinical Signs, Symptoms or Conditions 144 146
Blister 122 122
Itching Sensation 98 98
Rash 82 83
Erythema 55 55
Burning Sensation 52 52
Skin Tears 39 39
Burn(s) 34 34
Hypersensitivity/Allergic reaction 32 32
No Known Impact Or Consequence To Patient 21 21
Pain 18 18
Skin Irritation 18 18
Skin Burning Sensation 12 12
Partial thickness (Second Degree) Burn 12 12
Insufficient Information 12 13
Localized Skin Lesion 11 11
Superficial (First Degree) Burn 10 10
Peeling 10 10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 9 9
Bruise/Contusion 8 9
Foreign Body In Patient 7 7
Irritation 7 7
Full thickness (Third Degree) Burn 7 7
No Consequences Or Impact To Patient 7 7
Swelling/ Edema 6 6
Skin Infection 6 6
Skin Discoloration 6 6
Skin Inflammation 5 5
Reaction 5 6
Caustic/Chemical Burns 5 5
Hemorrhage/Blood Loss/Bleeding 4 4
Abrasion 4 4
Skin Disorders 4 4
Sore Throat 4 4
Contact Dermatitis 4 4
Scar Tissue 4 4
Discomfort 3 3
Unspecified Tissue Injury 3 3
Skin Erosion 3 3
Urticaria 3 3
Skin Maceration 3 3
Asystole 3 3
Anaphylactic Shock 3 3
Asthma 3 3
Airway Obstruction 2 2
Anaphylactoid / Anaphylaxis 2 2
Discharge 2 2
Dysphagia/ Odynophagia 2 2
Tachycardia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Nov-01-2021
2 3M Company - Health Care Business II Nov-05-2020
3 Graphic Controls Acquisition Corporation II Apr-14-2022
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