TPLC - Total Product Life Cycle

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Device	electrode, electrocardiograph
Regulation Description	Electrocardiograph electrode.
Product Code	DRX
Regulation Number	870.2360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	208	208
Biocompatibility	176	176
Insufficient Device Problem Information	66	66
Connection Problem	39	39
Failure to Sense	19	19
Human-Device Interface Problem	14	14
Fitting Problem	12	12
Device Sensing Problem	12	12
Patient-Device Incompatibility	11	11
Use of Device Problem	10	10
Failure to Deliver Shock/Stimulation	8	8
Patient Device Interaction Problem	8	8
Loose or Intermittent Connection	7	7
Incorrect Interpretation of Signal	7	7
Appropriate Device Problem Term/Code Not Available	7	7
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Overheating of Device	4	4
Disconnection	4	4
Product Quality Problem	4	4
Electrical /Electronic Property Problem	3	3
Loss of or Failure to Bond	3	3
Failure to Read Input Signal	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Component	3	4
Failure to Transmit Record	2	2
Defibrillation/Stimulation Problem	2	2
Material Integrity Problem	2	2
Image Display Error/Artifact	1	2
Failure to Deliver Energy	1	1
Unintended Electrical Shock	1	1
Device Handling Problem	1	1
No Apparent Adverse Event	1	1
Unintended Movement	1	1
Temperature Problem	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Separation	1	1
Material Too Rigid or Stiff	1	1
Failure to Analyze Signal	1	1
Peeled/Delaminated	1	1
Pacing Problem	1	1
Mechanical Problem	1	1
Leak/Splash	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	345	345
No Clinical Signs, Symptoms or Conditions	144	146
Blister	122	122
Itching Sensation	94	94
Rash	77	78
Burning Sensation	52	52
Erythema	52	52
Burn(s)	32	32
Skin Tears	30	30
Hypersensitivity/Allergic reaction	27	27
Pain	17	17
Skin Burning Sensation	12	12
Insufficient Information	12	13
Localized Skin Lesion	11	11
Partial thickness (Second Degree) Burn	11	11
Peeling	10	10
No Known Impact Or Consequence To Patient	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Superficial (First Degree) Burn	9	9
Skin Irritation	9	9
Bruise/Contusion	8	9
Full thickness (Third Degree) Burn	7	7
Swelling/ Edema	6	6
Skin Infection	6	6
Skin Discoloration	6	6
Foreign Body In Patient	5	5
No Consequences Or Impact To Patient	5	5
Caustic/Chemical Burns	5	5
Irritation	4	4
Abrasion	4	4
Skin Disorders	4	4
Reaction	4	5
Hemorrhage/Blood Loss/Bleeding	4	4
Contact Dermatitis	4	4
Scar Tissue	4	4
Discomfort	3	3
Asystole	3	3
Skin Erosion	3	3
Urticaria	3	3
Skin Maceration	3	3
Unspecified Tissue Injury	3	3
Anaphylactic Shock	3	3
Sore Throat	3	3
Skin Inflammation	3	3
Inflammation	2	2
Unspecified Infection	2	2
Airway Obstruction	2	2
Ecchymosis	2	2
Tachycardia	2	2
Ventricular Fibrillation	2	2

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