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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
2020 53 53
2021 55 55
2022 61 61
2023 113 113
2024 61 61
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Insufficient Information 54 54
Connection Problem 38 38
Patient-Device Incompatibility 22 22
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Fitting Problem 12 12
Use of Device Problem 9 9
Device Sensing Problem 8 8
Failure to Deliver Shock/Stimulation 8 8
Patient Device Interaction Problem 7 7
Loose or Intermittent Connection 7 7
Incorrect Interpretation of Signal 6 6
Appropriate Term/Code Not Available 6 6
Loss of or Failure to Bond 5 5
Defective Component 4 4
Biocompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Disconnection 4 4
Failure to Read Input Signal 3 3
Detachment of Device or Device Component 3 3
Physical Resistance/Sticking 3 3
Electrical /Electronic Property Problem 3 3
Defective Device 3 3
Material Integrity Problem 2 2
Failure to Transmit Record 2 2
Overheating of Device 2 2
Unable to Obtain Readings 2 2
Component Missing 2 2
Defibrillation/Stimulation Problem 2 2
Inaccurate Information 1 1
Temperature Problem 1 1
Peeled/Delaminated 1 1
Failure to Analyze Signal 1 1
Device Handling Problem 1 1
Mechanical Problem 1 1
Image Display Error/Artifact 1 1
Premature Discharge of Battery 1 1
Positioning Failure 1 1
Signal Artifact/Noise 1 1
Unintended Movement 1 1
Entrapment of Device 1 1
Mechanical Jam 1 1
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Gel Leak 1 1
Material Too Rigid or Stiff 1 1
Break 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 116 116
Blister 43 43
Skin Inflammation/ Irritation 39 39
Rash 30 30
Skin Tears 23 23
Itching Sensation 23 23
Burn(s) 22 22
Erythema 19 19
Hypersensitivity/Allergic reaction 19 19
Burning Sensation 10 10
Insufficient Information 10 10
Pain 10 10
No Known Impact Or Consequence To Patient 10 10
Skin Burning Sensation 9 9
Partial thickness (Second Degree) Burn 9 9
Skin Irritation 9 9
Localized Skin Lesion 7 7
Peeling 6 6
Swelling/ Edema 6 6
Bruise/Contusion 6 6
Skin Discoloration 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Consequences Or Impact To Patient 5 5
Skin Infection 5 5
Reaction 4 4
Irritation 4 4
Superficial (First Degree) Burn 4 4
Abrasion 4 4
Full thickness (Third Degree) Burn 4 4
Hemorrhage/Bleeding 3 3
Contact Dermatitis 3 3
Skin Inflammation 3 3
Scar Tissue 3 3
Asystole 3 3
Caustic/Chemical Burns 3 3
Urticaria 3 3
Fall 2 2
Discomfort 2 2
Anaphylactic Shock 2 2
Cardiac Arrest 2 2
Skin Erosion 2 2
Ventricular Fibrillation 2 2
Local Reaction 2 2
Purulent Discharge 2 2
Ecchymosis 2 2
Foreign Body In Patient 2 2
Unspecified Tissue Injury 2 2
Unspecified Respiratory Problem 1 1
Inflammation 1 1
Unspecified Infection 1 1

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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