• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
2017 54 54
2018 43 43
2019 50 50
2020 53 53
2021 55 55
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 75 75
Adverse Event Without Identified Device or Use Problem 69 69
Patient-Device Incompatibility 20 20
Failure to Sense 14 14
Device Sensing Problem 9 9
Appropriate Term/Code Not Available 7 7
Improper or Incorrect Procedure or Method 7 7
Detachment of Device or Device Component 6 6
Failure to Deliver Shock/Stimulation 6 6
Patient Device Interaction Problem 6 6
Missing Value Reason 5 5
Incorrect Interpretation of Signal 5 5
Connection Problem 5 5
Defective Component 5 5
Component Missing 5 5
Material Separation 4 4
Device Operates Differently Than Expected 4 4
Unable to Obtain Readings 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Electrical /Electronic Property Problem 3 3
Break 3 3
Device Handling Problem 3 3
Physical Resistance/Sticking 3 3
Mechanical Jam 2 2
Loss of or Failure to Bond 2 2
Disconnection 2 2
Entrapment of Device 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Overheating of Device 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
Shipping Damage or Problem 1 1
Device Packaging Compromised 1 1
Activation, Positioning or Separation Problem 1 1
Fitting Problem 1 1
Computer Operating System Problem 1 1
Pacing Inadequately 1 1
Product Quality Problem 1 1
Failure to Analyze Signal 1 1
Failure to Transmit Record 1 1
Device Appears to Trigger Rejection 1 1
Positioning Failure 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Failure To Adhere Or Bond 1 1
Signal Artifact/Noise 1 1
Premature Discharge of Battery 1 1
Device Fell 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Missing Information 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 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
Skin Irritation 37 37
No Clinical Signs, Symptoms or Conditions 37 37
No Known Impact Or Consequence To Patient 33 33
Rash 30 30
Itching Sensation 21 21
Burn(s) 20 20
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
Lead(s), Burn(s) From 7 7
Pain 7 7
Insufficient Information 6 6
Skin Infection 5 5
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 Burning Sensation 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
Anaphylactic Shock 2 2
Asthma 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 2 2
Fall 2 2
Discharge 2 2
Burn, Thermal 2 2
No Patient Involvement 2 2
Patient Problem/Medical Problem 2 2
Asystole 2 2
Unspecified Respiratory Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Contact Dermatitis 1 1
Swelling/ Edema 1 1
Skin Disorders 1 1
Tissue Breakdown 1 1
Caustic/Chemical Burns 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Sneezing 1 1
Dizziness 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
Radiation Burn 1 1
Skin Erosion 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
-
-