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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 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 75 75
Adverse Event Without Identified Device or Use Problem 65 65
Patient-Device Incompatibility 20 20
Failure to Sense 14 14
Device Sensing Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 6 6
Incorrect Interpretation of Signal 5 5
Missing Value Reason 5 5
Detachment of Device or Device Component 5 5
Component Missing 5 5
Connection Problem 5 5
Unable to Obtain Readings 4 4
Failure to Deliver Shock/Stimulation 4 4
Material Separation 4 4
Device Operates Differently Than Expected 4 4
Defective Component 4 4
Physical Resistance/Sticking 3 3
Device Handling Problem 3 3
Break 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Electrical /Electronic Property Problem 3 3
Entrapment of Device 2 2
Loose or Intermittent Connection 2 2
Disconnection 2 2
Defibrillation/Stimulation Problem 2 2
Use of Device Problem 2 2
Defective Device 2 2
Loss of or Failure to Bond 2 2
Mechanical Problem 2 2
Overheating of Device 2 2
Mechanical Jam 2 2
Incomplete or Missing Packaging 2 2
Failure to Read Input Signal 2 2
Device Fell 1 1
Missing Information 1 1
Device-Device Incompatibility 1 1
Material Integrity Problem 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
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
Activation, Positioning or SeparationProblem 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
Separation 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
Electrical Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 37 37
No Known Impact Or Consequence To Patient 33 33
No Clinical Signs, Symptoms or Conditions 30 30
Rash 30 30
Itching Sensation 21 21
Burn(s) 19 19
Skin Tears 19 19
Skin Inflammation/ Irritation 18 18
Erythema 16 16
Hypersensitivity/Allergic reaction 15 15
Burning Sensation 12 12
Reaction 11 11
No Information 10 10
Blister 10 10
No Consequences Or Impact To Patient 8 8
Irritation 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
Death 5 5
Abrasion 4 4
Superficial (First Degree) Burn 4 4
Foreign Body In Patient 4 4
Skin Infection 4 4
Localized Skin Lesion 3 3
Sore Throat 3 3
Urticaria 3 3
Discomfort 3 3
Bruise/Contusion 3 3
Skin Discoloration 3 3
Tissue Damage 3 3
Unspecified Infection 3 3
Local Reaction 3 3
Scar Tissue 3 3
Scarring 2 2
Nausea 2 2
Ventricular Fibrillation 2 2
Peeling 2 2
Cardiac Arrest 2 2
Asthma 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 2 2
Fall 2 2
Burn, Thermal 2 2
Patient Problem/Medical Problem 2 2
No Patient Involvement 2 2
Discharge 2 2
Skin Burning Sensation 2 2
Asystole 2 2
Unspecified Respiratory Problem 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sneezing 1 1
Dizziness 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Tissue Breakdown 1 1
Caustic/Chemical Burns 1 1
Injury 1 1
Hair Loss 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Low Blood Pressure/ Hypotension 1 1
Bradycardia 1 1
Anaphylactic Shock 1 1
Radiation Burn 1 1
Swelling 1 1
Necrosis 1 1
Inflammation 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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