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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


Premarket Reviews
ManufacturerDecision
NIMBLEHEART, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 54 54
2018 43 43
2019 50 50
2020 53 53
2021 55 55
2022 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 75 75
Adverse Event Without Identified Device or Use Problem 70 70
Patient-Device Incompatibility 21 21
Failure to Sense 14 14
Connection Problem 11 11
Device Sensing Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Appropriate Term/Code Not Available 7 7
Detachment of Device or Device Component 6 6
Failure to Deliver Shock/Stimulation 6 6
Patient Device Interaction Problem 6 6
Incorrect Interpretation of Signal 5 5
Defective Component 5 5
Missing Value Reason 5 5
Component Missing 5 5
Unable to Obtain Readings 4 4
Material Separation 4 4
Device Operates Differently Than Expected 4 4
Device Handling Problem 3 3
Fitting Problem 3 3
Physical Resistance/Sticking 3 3
Disconnection 3 3
Electrical /Electronic Property Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Break 3 3
Use of Device Problem 2 2
Mechanical Problem 2 2
Overheating of Device 2 2
Loss of or Failure to Bond 2 2
Defective Device 2 2
Entrapment of Device 2 2
Loose or Intermittent Connection 2 2
Defibrillation/Stimulation Problem 2 2
Failure to Read Input Signal 2 2
Mechanical Jam 2 2
Incomplete or Missing Packaging 2 2
Positioning Failure 1 1
Pacing Inadequately 1 1
Device Packaging Compromised 1 1
Human-Device Interface Problem 1 1
Computer Operating System Problem 1 1
Inaccurate Information 1 1
Failure To Adhere Or Bond 1 1
Detachment Of Device Component 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Device Fell 1 1
Missing Information 1 1
Device-Device Incompatibility 1 1
Material Integrity Problem 1 1
Electrical Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Transmit Record 1 1
Failure to Analyze Signal 1 1
Premature Discharge of Battery 1 1
Thermal Decomposition of Device 1 1
Activation, Positioning or Separation Problem 1 1
Signal Artifact/Noise 1 1
Shipping Damage or Problem 1 1
Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
Skin Irritation 37 37
No Known Impact Or Consequence To Patient 33 33
Rash 30 30
Burn(s) 22 22
Itching Sensation 21 21
Skin Tears 20 20
Skin Inflammation/ Irritation 18 18
Erythema 17 17
Hypersensitivity/Allergic reaction 15 15
Burning Sensation 12 12
Blister 12 12
Reaction 11 11
No Information 10 10
Irritation 8 8
No Consequences Or Impact To Patient 8 8
Pain 7 7
Lead(s), Burn(s) From 7 7
Insufficient Information 6 6
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 5 5
Skin Inflammation 5 5
Skin Infection 5 5
Death 5 5
Foreign Body In Patient 4 4
Skin Burning Sensation 4 4
Abrasion 4 4
Superficial (First Degree) Burn 4 4
Skin Discoloration 3 3
Scar Tissue 3 3
Unspecified Infection 3 3
Sore Throat 3 3
Urticaria 3 3
Discomfort 3 3
Bruise/Contusion 3 3
Localized Skin Lesion 3 3
Local Reaction 3 3
Tissue Damage 3 3
Nausea 2 2
Anaphylactic Shock 2 2
Patient Problem/Medical Problem 2 2
Asystole 2 2
Swelling/ Edema 2 2
Dyspnea 2 2
Fall 2 2
Discharge 2 2
Scarring 2 2
Ventricular Fibrillation 2 2
Asthma 2 2
Cardiac Arrest 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Peeling 2 2
Dysphagia/ Odynophagia 2 2
Unspecified Respiratory Problem 1 1
Contact Dermatitis 1 1
Sneezing 1 1
Sudden Cardiac Death 1 1
Caustic/Chemical Burns 1 1
Tissue Breakdown 1 1
Purulent Discharge 1 1
Hair Loss 1 1
Headache 1 1
Injury 1 1
Dizziness 1 1
Shaking/Tremors 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Radiation Burn 1 1
Skin Erosion 1 1
Swelling 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Skin Disorders 1 1
Bradycardia 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Necrosis 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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