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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 50 50
2020 53 53
2021 55 55
2022 61 61
2023 113 113
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 73 73
Adverse Event Without Identified Device or Use Problem 56 56
Connection Problem 37 37
Patient-Device Incompatibility 25 25
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Fitting Problem 12 12
Device Sensing Problem 9 9
Patient Device Interaction Problem 8 8
Use of Device Problem 8 8
Loose or Intermittent Connection 7 7
Failure to Deliver Shock/Stimulation 6 6
Incorrect Interpretation of Signal 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Defective Component 5 5
Loss of or Failure to Bond 5 5
Detachment of Device or Device Component 5 5
Disconnection 4 4
Improper or Incorrect Procedure or Method 4 4
Failure to Read Input Signal 3 3
Electrical /Electronic Property Problem 3 3
Unable to Obtain Readings 3 3
Mechanical Problem 3 3
Defective Device 3 3
Physical Resistance/Sticking 3 3
Appropriate Term/Code Not Available 3 3
Device Handling Problem 2 2
Overheating of Device 2 2
Failure to Transmit Record 2 2
Entrapment of Device 2 2
Break 2 2
Defibrillation/Stimulation Problem 2 2
Material Separation 2 2
Biocompatibility 2 2
Component Missing 2 2
Incomplete or Missing Packaging 2 2
Computer Operating System Problem 1 1
Shipping Damage or Problem 1 1
Failure to Analyze Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Signal Artifact/Noise 1 1
Premature Discharge of Battery 1 1
Gel Leak 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1
Device Appears to Trigger Rejection 1 1
Positioning Failure 1 1
Pacing Inadequately 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Device Fell 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Output Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Activation, Positioning or Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 105
Blister 33 33
Skin Inflammation/ Irritation 31 31
Skin Tears 31 31
Rash 31 31
Itching Sensation 26 26
Burn(s) 21 21
Hypersensitivity/Allergic reaction 21 21
No Known Impact Or Consequence To Patient 21 21
Erythema 20 20
Skin Irritation 18 18
Burning Sensation 10 10
Insufficient Information 9 9
Skin Burning Sensation 8 8
Pain 8 8
Irritation 7 7
Localized Skin Lesion 7 7
No Consequences Or Impact To Patient 7 7
Peeling 6 6
Bruise/Contusion 6 6
Skin Discoloration 5 5
Reaction 5 5
Skin Inflammation 5 5
Partial thickness (Second Degree) Burn 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Infection 5 5
Swelling/ Edema 5 5
Superficial (First Degree) Burn 5 5
Foreign Body In Patient 4 4
Abrasion 4 4
Scar Tissue 3 3
Asystole 3 3
Caustic/Chemical Burns 3 3
Urticaria 3 3
Discharge 2 2
Skin Erosion 2 2
Ventricular Fibrillation 2 2
Sore Throat 2 2
Contact Dermatitis 2 2
Unspecified Tissue Injury 2 2
Ecchymosis 2 2
Hemorrhage/Bleeding 2 2
Anaphylactic Shock 2 2
Asthma 2 2
Cardiac Arrest 2 2
Fall 2 2
Purulent Discharge 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1
Death 1 1
Radiation Burn 1 1
Bradycardia 1 1
Hyperemia 1 1
Nausea 1 1
Necrosis 1 1
Scarring 1 1
Local Reaction 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Unspecified Respiratory Problem 1 1
Skin Disorders 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Dizziness 1 1
Sneezing 1 1
Discomfort 1 1
Injury 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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