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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
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC LEAD TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMMWELL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
I NEEDMD, INC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRAL PROCESS SAS
  SUBSTANTIALLY EQUIVALENT 1
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 1
NIMBLEHEART, INC.
  SUBSTANTIALLY EQUIVALENT 1
R & D MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TEAM INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEPHYR TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 27 27
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 152 152
Adverse Event Without Identified Device or Use Problem 91 91
Patient-Device Incompatibility 42 42
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 Operates Differently Than Expected 10 10
Device Sensing Problem 9 9
Use of Device Problem 9 9
Appropriate Term/Code Not Available 9 9
No Display/Image 8 8
Incorrect Interpretation of Signal 8 8
Patient Device Interaction Problem 8 8
Disconnection 7 7
Loose or Intermittent Connection 7 7
Defective Component 7 7
Loss of or Failure to Bond 6 6
Missing Value Reason 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Detachment of Device or Device Component 6 6
Failure to Deliver Shock/Stimulation 6 6
Unable to Obtain Readings 5 5
Component Missing 5 5
Failure To Adhere Or Bond 5 5
Failure to Read Input Signal 5 5
No Apparent Adverse Event 4 4
Electrical /Electronic Property Problem 4 4
Break 4 4
Material Separation 4 4
Physical Resistance/Sticking 4 4
Detachment Of Device Component 3 3
Device Handling Problem 3 3
Mechanical Problem 3 3
Defective Device 3 3
Overheating of Device 3 3
Failure to Transmit Record 3 3
Device Dislodged or Dislocated 2 2
Material Integrity Problem 2 2
Sparking 2 2
Gel Leak 2 2
Defibrillation/Stimulation Problem 2 2
Entrapment of Device 2 2
Biocompatibility 2 2
Incomplete or Missing Packaging 2 2
Mechanical Jam 2 2
Device Contamination with Chemical or Other Material 2 2
Device-Device Incompatibility 1 1
Peeled/Delaminated 1 1
Image Display Error/Artifact 1 1
Unintended Movement 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure of Device to Self-Test 1 1
Leak/Splash 1 1
Computer Operating System Problem 1 1
Inaccurate Information 1 1
Device Packaging Compromised 1 1
Positioning Failure 1 1
Component Falling 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Analyze Signal 1 1
Thermal Decomposition of Device 1 1
Temperature Problem 1 1
Separation Problem 1 1
Failure to Discharge 1 1
Output Problem 1 1
Pacing Inadequately 1 1
False Reading From Device Non-Compliance 1 1
Communication or Transmission Problem 1 1
Device Appears to Trigger Rejection 1 1
Product Quality Problem 1 1
Device Fell 1 1
Missing Information 1 1
Unexpected Therapeutic Results 1 1
Activation, Positioning or Separation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Physical Property Issue 1 1
Signal Artifact/Noise 1 1
Shipping Damage or Problem 1 1
Device Displays Incorrect Message 1 1
Premature Discharge of Battery 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 105
Skin Irritation 79 79
Rash 50 50
Itching Sensation 43 43
No Known Impact Or Consequence To Patient 41 41
Burn(s) 39 39
Erythema 36 36
Blister 34 34
Skin Tears 33 33
Hypersensitivity/Allergic reaction 31 31
Skin Inflammation/ Irritation 31 31
Burning Sensation 20 20
No Information 17 17
Reaction 16 16
No Consequences Or Impact To Patient 13 13
Partial thickness (Second Degree) Burn 13 13
Lead(s), Burn(s) From 13 13
Skin Discoloration 12 12
Pain 11 11
Irritation 10 10
Insufficient Information 9 9
Skin Burning Sensation 8 8
Death 8 8
Bruise/Contusion 7 7
Localized Skin Lesion 7 7
Full thickness (Third Degree) Burn 6 6
Abrasion 6 6
Peeling 6 6
Superficial (First Degree) Burn 6 6
Swelling 6 6
Tissue Damage 6 6
Skin Erosion 5 5
No Patient Involvement 5 5
Sore Throat 5 5
Skin Inflammation 5 5
Scar Tissue 5 5
Scarring 5 5
Unspecified Infection 5 5
Foreign Body In Patient 5 5
Skin Infection 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Swelling/ Edema 5 5
Local Reaction 4 4
Discomfort 4 4
Burn, Thermal 4 4
Discharge 4 4
Urticaria 4 4
Caustic/Chemical Burns 3 3
Fluid Discharge 3 3
Hemorrhage/Bleeding 3 3
Purulent Discharge 3 3
Dyspnea 3 3
Asystole 3 3
Patient Problem/Medical Problem 2 2
Contact Dermatitis 2 2
Unspecified Tissue Injury 2 2
Ecchymosis 2 2
Dysphagia/ Odynophagia 2 2
Fall 2 2
Hair Loss 2 2
Anaphylactic Shock 2 2
Asthma 2 2
Radiation Burn 2 2
Cardiac Arrest 2 2
Inflammation 2 2
Nausea 2 2
Injury 2 2
Ventricular Fibrillation 2 2
Tachycardia 1 1
Suffocation 1 1
Anxiety 1 1
Sneezing 1 1
Rupture 1 1
Dizziness 1 1
Impaired Healing 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Loss of consciousness 1 1
Tissue Breakdown 1 1
Sleep Dysfunction 1 1
Necrosis 1 1
Keratitis 1 1
Hyperemia 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Cellulitis 1 1
Bradycardia 1 1
Headache 1 1
Edema 1 1
Skin Disorders 1 1
Unspecified Respiratory Problem 1 1
No Code 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 3M Company / Medical Division II Sep-07-2010
4 Cambridge Heart, Inc. II Jun-07-2010
5 ConMed Corporation II Mar-02-2011
6 ConvaTec II Apr-22-2010
7 Graphic Controls Acquisition Corporation II Apr-14-2022
8 Leonhard Lang Medizintechnik GmbH II Nov-18-2015
9 Leonhard Lang Medizintechnik GmbH II Mar-28-2015
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