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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
2015 57 57
2016 37 37
2017 54 54
2018 43 43
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 137 137
Adverse Event Without Identified Device or Use Problem 89 89
Patient-Device Incompatibility 40 40
Connection Problem 37 37
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Fitting Problem 12 12
Device Sensing Problem 9 9
Use of Device Problem 9 9
Device Operates Differently Than Expected 8 8
Appropriate Term/Code Not Available 8 8
Patient Device Interaction Problem 8 8
Incorrect Interpretation of Signal 8 8
No Display/Image 8 8
Loose or Intermittent Connection 7 7
Disconnection 7 7
Defective Component 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Loss of or Failure to Bond 6 6
Failure to Deliver Shock/Stimulation 6 6
Missing Value Reason 6 6
Detachment of Device or Device Component 6 6
Failure To Adhere Or Bond 5 5
Unable to Obtain Readings 5 5
Component Missing 5 5
Failure to Read Input Signal 5 5
Material Separation 4 4
Break 4 4
Electrical /Electronic Property Problem 4 4
Physical Resistance/Sticking 4 4
No Apparent Adverse Event 4 4
Device Handling Problem 3 3
Defective Device 3 3
Mechanical Problem 3 3
Failure to Transmit Record 3 3
Gel Leak 2 2
Incomplete or Missing Packaging 2 2
Overheating of Device 2 2
Entrapment of Device 2 2
Defibrillation/Stimulation Problem 2 2
Biocompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanical Jam 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Device Fell 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Missing Information 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Device Packaging Compromised 1 1
Activation, Positioning or Separation Problem 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Failure of Device to Self-Test 1 1
False Reading From Device Non-Compliance 1 1
Pacing Inadequately 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Signal Artifact/Noise 1 1
Premature Discharge of Battery 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1
Device Appears to Trigger Rejection 1 1
Failure to Analyze Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 105
Skin Irritation 74 74
Rash 46 46
No Known Impact Or Consequence To Patient 40 40
Itching Sensation 39 39
Burn(s) 39 39
Blister 34 34
Skin Tears 33 33
Skin Inflammation/ Irritation 31 31
Erythema 29 29
Hypersensitivity/Allergic reaction 28 28
Burning Sensation 18 18
No Information 16 16
Reaction 14 14
No Consequences Or Impact To Patient 13 13
Lead(s), Burn(s) From 13 13
Partial thickness (Second Degree) Burn 10 10
Pain 10 10
Irritation 9 9
Skin Discoloration 9 9
Insufficient Information 9 9
Skin Burning Sensation 8 8
Localized Skin Lesion 7 7
Bruise/Contusion 7 7
Death 6 6
Peeling 6 6
Superficial (First Degree) Burn 6 6
Full thickness (Third Degree) Burn 5 5
Skin Inflammation 5 5
No Patient Involvement 5 5
Scar Tissue 5 5
Scarring 5 5
Abrasion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Infection 5 5
Swelling/ Edema 5 5
Local Reaction 4 4
Unspecified Infection 4 4
Foreign Body In Patient 4 4
Tissue Damage 4 4
Urticaria 4 4
Discomfort 3 3
Sore Throat 3 3
Discharge 3 3
Swelling 3 3
Burn, Thermal 3 3
Caustic/Chemical Burns 3 3
Hemorrhage/Bleeding 3 3
Purulent Discharge 3 3
Dyspnea 3 3
Asystole 3 3
Contact Dermatitis 2 2
Unspecified Tissue Injury 2 2
Ecchymosis 2 2
Dysphagia/ Odynophagia 2 2
Fall 2 2
Anaphylactic Shock 2 2
Asthma 2 2
Radiation Burn 2 2
Cardiac Arrest 2 2
Nausea 2 2
Patient Problem/Medical Problem 2 2
Skin Erosion 2 2
Ventricular Fibrillation 2 2
Injury 2 2
Sneezing 1 1
Rupture 1 1
Dizziness 1 1
Tachycardia 1 1
Skin Disorders 1 1
Tissue Breakdown 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Necrosis 1 1
Hyperemia 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Keratitis 1 1
Cellulitis 1 1
Bradycardia 1 1
Hair Loss 1 1
Headache 1 1
Unspecified Respiratory Problem 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
4 Leonhard Lang Medizintechnik GmbH II Nov-18-2015
5 Leonhard Lang Medizintechnik GmbH II Mar-28-2015
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