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	209	209
Biocompatibility	192	192
Insufficient Device Problem Information	48	48
Connection Problem	39	39
Human-Device Interface Problem	14	14
Fitting Problem	12	12
Patient-Device Incompatibility	11	11
Failure to Sense	11	11
Use of Device Problem	9	9
Failure to Deliver Shock/Stimulation	8	8
Patient Device Interaction Problem	8	8
Loose or Intermittent Connection	7	7
Device Sensing Problem	7	7
Appropriate Device Problem Term/Code Not Available	6	6
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Disconnection	4	4
Product Quality Problem	4	4
Loss of or Failure to Bond	3	3
Improper or Incorrect Procedure or Method	3	3
Electrical /Electronic Property Problem	3	3
Overheating of Device	3	3
Incorrect Interpretation of Signal	3	3
Defective Component	3	4
Failure to Read Input Signal	3	3
Material Integrity Problem	2	2
Defibrillation/Stimulation Problem	2	2
Failure to Transmit Record	2	2
Material Too Rigid or Stiff	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Computer Software Problem	1	1
Pacing Problem	1	1
Device Dislodged or Dislocated	1	1
Unintended Movement	1	1
Unintended Electrical Shock	1	1
Peeled/Delaminated	1	1
Image Display Error/Artifact	1	2
Failure to Analyze Signal	1	1
Mechanical Problem	1	1
Separation Problem	1	1
Activation, Positioning or Separation Problem	1	1
Leak/Splash	1	1
Failure to Deliver Energy	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	366	366
No Clinical Signs, Symptoms or Conditions	135	137
Blister	125	125
Itching Sensation	93	93
Rash	71	71
Erythema	54	54
Burning Sensation	50	50
Burn(s)	28	28
Hypersensitivity/Allergic reaction	27	27
Skin Tears	25	25
Pain	15	15
Skin Burning Sensation	12	12
Insufficient Information	12	13
Localized Skin Lesion	11	11
Partial thickness (Second Degree) Burn	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Peeling	9	9
Superficial (First Degree) Burn	8	8
Full thickness (Third Degree) Burn	7	7
Swelling/ Edema	7	7
Hemorrhage/Blood Loss/Bleeding	5	5
Skin Infection	5	5
Bruise/Contusion	5	5
Skin Discoloration	5	5
Caustic/Chemical Burns	4	4
Contact Dermatitis	4	4
Scar Tissue	4	4
Skin Disorders	4	4
Foreign Body In Patient	4	4
Anaphylactoid / Anaphylaxis	4	4
Discomfort	3	3
Skin Erosion	3	3
Skin Maceration	3	3
Asystole	3	3
Anaphylactic Shock	3	3
Unspecified Tissue Injury	3	3
Abrasion	3	3
Sore Throat	3	3
Urticaria	3	3
Fluid Discharge	2	2
Tachycardia	2	2
Airway Obstruction	2	2
Angioedema	2	2
Fall	2	2
Ecchymosis	2	2
Dyspnea	2	2
Chest Pain	2	2
Ventricular Fibrillation	2	2
Cardiac Arrest	2	2
Local Reaction	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Nov-01-2021
2	Graphic Controls Acquisition Corporation	II	Apr-14-2022