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TPLC
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show TPLC since
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Device
electrode, electrocardiograph
Product Code
DRX
Regulation Number
870.2360
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
43
43
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
154
154
Adverse Event Without Identified Device or Use Problem
93
93
Patient-Device Incompatibility
42
42
Connection Problem
38
38
Failure to Sense
19
19
Improper or Incorrect Procedure or Method
14
14
Human-Device Interface Problem
14
14
Fitting Problem
12
12
Appropriate Term/Code Not Available
11
11
Device Operates Differently Than Expected
10
10
Use of Device Problem
10
10
Device Sensing Problem
9
9
Incorrect Interpretation of Signal
8
8
Failure to Deliver Shock/Stimulation
8
8
No Display/Image
8
8
Patient Device Interaction Problem
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
Detachment of Device or Device Component
6
6
Missing Value Reason
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
No Apparent Adverse Event
4
4
Biocompatibility
4
4
Physical Resistance/Sticking
4
4
Defective Device
3
3
Device Handling Problem
3
3
Mechanical Problem
3
3
Overheating of Device
3
3
Detachment Of Device Component
3
3
Failure to Transmit Record
3
3
Gel Leak
2
2
Incomplete or Missing Packaging
2
2
Entrapment of Device
2
2
Device Contamination with Chemical or Other Material
2
2
Material Integrity Problem
2
2
Mechanical Jam
2
2
Device Dislodged or Dislocated
2
2
Defibrillation/Stimulation Problem
2
2
Sparking
2
2
Activation, Positioning or Separation Problem
1
1
Device-Device Incompatibility
1
1
Device Packaging Compromised
1
1
Device Displays Incorrect Message
1
1
Communication or Transmission Problem
1
1
Computer Operating System Problem
1
1
Electrical Power Problem
1
1
Failure of Device to Self-Test
1
1
Manufacturing, Packaging or Shipping 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
False Reading From Device Non-Compliance
1
1
Pacing Inadequately
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Component Falling
1
1
Positioning Failure
1
1
Failure to Discharge
1
1
Thermal Decomposition of Device
1
1
Signal Artifact/Noise
1
1
Premature Discharge of Battery
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
Device Fell
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Missing Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
109
109
Skin Irritation
79
79
Rash
53
53
Itching Sensation
43
43
Burn(s)
41
41
No Known Impact Or Consequence To Patient
41
41
Erythema
37
37
Blister
36
36
Skin Inflammation/ Irritation
36
36
Hypersensitivity/Allergic reaction
33
33
Skin Tears
33
33
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
Local Reaction
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
Hemorrhage/Bleeding
4
4
Discomfort
4
4
Fluid Discharge
4
4
Burn, Thermal
4
4
Discharge
4
4
Urticaria
4
4
Caustic/Chemical Burns
3
3
Purulent Discharge
3
3
Dyspnea
3
3
Contact Dermatitis
3
3
Asystole
3
3
Patient Problem/Medical Problem
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
Sleep Dysfunction
1
1
Tissue Breakdown
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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