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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
2016 37 37
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 86 86
Adverse Event Without Identified Device or Use Problem 70 70
Patient-Device Incompatibility 25 25
Failure to Sense 14 14
Improper or Incorrect Procedure or Method 13 13
Device Sensing Problem 9 9
Appropriate Term/Code Not Available 7 7
Missing Value Reason 6 6
Patient Device Interaction Problem 6 6
Device Operates Differently Than Expected 6 6
Incorrect Interpretation of Signal 6 6
Component Missing 5 5
Connection Problem 5 5
Detachment of Device or Device Component 5 5
Defective Component 4 4
Material Separation 4 4
Break 4 4
Failure to Deliver Shock/Stimulation 4 4
Unable to Obtain Readings 4 4
Disconnection 3 3
Electrical /Electronic Property Problem 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Physical Resistance/Sticking 3 3
Device Handling Problem 3 3
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Loss of or Failure to Bond 2 2
Defibrillation/Stimulation Problem 2 2
Failure to Read Input Signal 2 2
Use of Device Problem 2 2
Incomplete or Missing Packaging 2 2
Defective Device 2 2
Entrapment of Device 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Overheating of Device 2 2
Pacing Inadequately 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Device Appears to Trigger Rejection 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
False Reading From Device Non-Compliance 1 1
Gel Leak 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Failure To Adhere Or Bond 1 1
Premature Discharge of Battery 1 1
Activation, Positioning or SeparationProblem 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Failure to Analyze Signal 1 1
Device Packaging Compromised 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 45 45
Rash 35 35
No Known Impact Or Consequence To Patient 35 35
No Clinical Signs, Symptoms or Conditions 30 30
Itching Sensation 26 26
Burn(s) 24 24
Hypersensitivity/Allergic reaction 19 19
Skin Tears 19 19
Skin Inflammation/ Irritation 18 18
Erythema 17 17
Burning Sensation 15 15
Reaction 13 13
Lead(s), Burn(s) From 13 13
No Information 12 12
Blister 11 11
Irritation 8 8
No Consequences Or Impact To Patient 8 8
Pain 7 7
Death 6 6
Insufficient Information 6 6
Scarring 5 5
Skin Discoloration 5 5
Skin Inflammation 5 5
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 5 5
Superficial (First Degree) Burn 5 5
Foreign Body In Patient 4 4
Tissue Damage 4 4
Unspecified Infection 4 4
Abrasion 4 4
Skin Infection 4 4
Bruise/Contusion 3 3
Dyspnea 3 3
Local Reaction 3 3
Scar Tissue 3 3
No Patient Involvement 3 3
Localized Skin Lesion 3 3
Sore Throat 3 3
Discharge 3 3
Urticaria 3 3
Discomfort 3 3
Injury 2 2
Burn, Thermal 2 2
Skin Burning Sensation 2 2
Patient Problem/Medical Problem 2 2
Asystole 2 2
Ventricular Fibrillation 2 2
Swelling 2 2
Peeling 2 2
Nausea 2 2
Dysphagia/ Odynophagia 2 2
Fall 2 2
Cardiac Arrest 2 2
Asthma 2 2
Bradycardia 1 1
Anaphylactic Shock 1 1
Cellulitis 1 1
Radiation Burn 1 1
Hair Loss 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Purulent Discharge 1 1
Necrosis 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Respiratory Problem 1 1
Tissue Breakdown 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Swelling/ Edema 1 1
Caustic/Chemical Burns 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Sneezing 1 1
Rupture 1 1
Dizziness 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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