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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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 154 154
Adverse Event Without Identified Device or Use Problem 96 96
Patient-Device Incompatibility 42 42
Connection Problem 38 38
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Improper or Incorrect Procedure or Method 14 14
Fitting Problem 12 12
Appropriate Term/Code Not Available 12 12
Use of Device Problem 10 10
Device Operates Differently Than Expected 10 10
Device Sensing Problem 9 9
Patient Device Interaction Problem 9 9
No Display/Image 8 8
Incorrect Interpretation of Signal 8 8
Failure to Deliver Shock/Stimulation 8 8
Defective Component 7 7
Disconnection 7 7
Loose or Intermittent Connection 7 7
Loss of or Failure to Bond 6 6
Detachment of Device or Device Component 6 6
Missing Value Reason 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Material Separation 5 5
Failure to Read Input Signal 5 5
Component Missing 5 5
Failure To Adhere Or Bond 5 5
Unable to Obtain Readings 5 5
Electrical /Electronic Property Problem 4 4
No Apparent Adverse Event 4 4
Biocompatibility 4 4
Physical Resistance/Sticking 4 4
Break 4 4
Overheating of Device 3 3
Detachment Of Device Component 3 3
Device Handling Problem 3 3
Mechanical Problem 3 3
Material Integrity Problem 3 3
Defective Device 3 3
Failure to Transmit Record 3 3
Gel Leak 2 2
Defibrillation/Stimulation Problem 2 2
Mechanical Jam 2 2
Device Contamination with Chemical or Other Material 2 2
Device Dislodged or Dislocated 2 2
Sparking 2 2
Entrapment of Device 2 2
Incomplete or Missing Packaging 2 2
Inadequacy of Device Shape and/or Size 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
Skin Irritation 79 79
Rash 54 54
Itching Sensation 43 43
Burn(s) 42 42
No Known Impact Or Consequence To Patient 41 41
Erythema 38 38
Blister 38 38
Skin Inflammation/ Irritation 37 37
Hypersensitivity/Allergic reaction 33 33
Skin Tears 33 33
Burning Sensation 20 20
No Information 17 17
Reaction 16 16
Partial thickness (Second Degree) Burn 14 14
Lead(s), Burn(s) From 13 13
No Consequences Or Impact To Patient 13 13
Pain 12 12
Skin Discoloration 12 12
Insufficient Information 10 10
Irritation 10 10
Skin Burning Sensation 9 9
Death 8 8
Bruise/Contusion 7 7
Localized Skin Lesion 7 7
Full thickness (Third Degree) Burn 6 6
Superficial (First Degree) Burn 6 6
Tissue Damage 6 6
Swelling/ Edema 6 6
Peeling 6 6
Abrasion 6 6
Swelling 6 6
Sore Throat 5 5
Scar Tissue 5 5
No Patient Involvement 5 5
Skin Inflammation 5 5
Foreign Body In Patient 5 5
Skin Erosion 5 5
Unspecified Infection 5 5
Skin Infection 5 5
Scarring 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Local Reaction 5 5
Urticaria 4 4
Burn, Thermal 4 4
Hemorrhage/Bleeding 4 4
Discharge 4 4
Discomfort 4 4
Fluid Discharge 4 4
Caustic/Chemical Burns 3 3

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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