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TPLC
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Device
electrode, electrocardiograph
Regulation Description
Electrocardiograph electrode.
Product Code
DRX
Regulation Number
870.2360
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
53
53
2021
55
55
2022
61
61
2023
113
113
2024
61
61
2025
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
58
58
Insufficient Information
54
54
Connection Problem
38
38
Patient-Device Incompatibility
22
22
Failure to Sense
19
19
Human-Device Interface Problem
14
14
Fitting Problem
12
12
Use of Device Problem
9
9
Device Sensing Problem
8
8
Failure to Deliver Shock/Stimulation
8
8
Patient Device Interaction Problem
7
7
Loose or Intermittent Connection
7
7
Incorrect Interpretation of Signal
6
6
Appropriate Term/Code Not Available
6
6
Loss of or Failure to Bond
5
5
Defective Component
4
4
Biocompatibility
4
4
Improper or Incorrect Procedure or Method
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Disconnection
4
4
Failure to Read Input Signal
3
3
Detachment of Device or Device Component
3
3
Physical Resistance/Sticking
3
3
Electrical /Electronic Property Problem
3
3
Defective Device
3
3
Material Integrity Problem
2
2
Failure to Transmit Record
2
2
Overheating of Device
2
2
Unable to Obtain Readings
2
2
Component Missing
2
2
Defibrillation/Stimulation Problem
2
2
Inaccurate Information
1
1
Temperature Problem
1
1
Peeled/Delaminated
1
1
Failure to Analyze Signal
1
1
Device Handling Problem
1
1
Mechanical Problem
1
1
Image Display Error/Artifact
1
1
Premature Discharge of Battery
1
1
Positioning Failure
1
1
Signal Artifact/Noise
1
1
Unintended Movement
1
1
Entrapment of Device
1
1
Mechanical Jam
1
1
Shipping Damage or Problem
1
1
Product Quality Problem
1
1
Gel Leak
1
1
Material Too Rigid or Stiff
1
1
Break
1
1
Inadequacy of Device Shape and/or Size
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
116
116
Blister
43
43
Skin Inflammation/ Irritation
39
39
Rash
30
30
Skin Tears
23
23
Itching Sensation
23
23
Burn(s)
22
22
Erythema
19
19
Hypersensitivity/Allergic reaction
19
19
Burning Sensation
10
10
Insufficient Information
10
10
Pain
10
10
No Known Impact Or Consequence To Patient
10
10
Skin Burning Sensation
9
9
Partial thickness (Second Degree) Burn
9
9
Skin Irritation
9
9
Localized Skin Lesion
7
7
Peeling
6
6
Swelling/ Edema
6
6
Bruise/Contusion
6
6
Skin Discoloration
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Consequences Or Impact To Patient
5
5
Skin Infection
5
5
Reaction
4
4
Irritation
4
4
Superficial (First Degree) Burn
4
4
Abrasion
4
4
Full thickness (Third Degree) Burn
4
4
Hemorrhage/Bleeding
3
3
Contact Dermatitis
3
3
Skin Inflammation
3
3
Scar Tissue
3
3
Asystole
3
3
Caustic/Chemical Burns
3
3
Urticaria
3
3
Fall
2
2
Discomfort
2
2
Anaphylactic Shock
2
2
Cardiac Arrest
2
2
Skin Erosion
2
2
Ventricular Fibrillation
2
2
Local Reaction
2
2
Purulent Discharge
2
2
Ecchymosis
2
2
Foreign Body In Patient
2
2
Unspecified Tissue Injury
2
2
Unspecified Respiratory Problem
1
1
Inflammation
1
1
Unspecified Infection
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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