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	130	130
Biocompatibility	111	111
Insufficient Information	42	42
Connection Problem	41	41
Patient-Device Incompatibility	22	22
Human-Device Interface Problem	14	14
Patient Device Interaction Problem	13	13
Fitting Problem	12	12
Failure to Sense	11	11
Use of Device Problem	10	10
Loose or Intermittent Connection	8	8
Failure to Deliver Shock/Stimulation	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Device Sensing Problem	7	7
Loss of or Failure to Bond	6	6
Disconnection	5	5
Appropriate Term/Code Not Available	5	5
Product Quality Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Overheating of Device	4	4
Detachment of Device or Device Component	4	4
Defective Component	4	5
Material Integrity Problem	4	4
Failure to Read Input Signal	3	3
Electrical /Electronic Property Problem	3	3
Output Problem	3	3
Incorrect Interpretation of Signal	3	3
Defective Device	3	4
Defibrillation/Stimulation Problem	2	2
Material Separation	2	2
Unable to Obtain Readings	2	2
Difficult to Remove	2	2
Therapeutic or Diagnostic Output Failure	2	2
Failure to Transmit Record	2	2
Peeled/Delaminated	2	2
Physical Resistance/Sticking	2	2
Entrapment of Device	2	2
Signal Artifact/Noise	2	2
Shipping Damage or Problem	1	1
Adhesive Too Strong	1	1
Positioning Failure	1	2
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Environmental Compatibility Problem	1	1
Unintended Movement	1	1
Inadequacy of Device Shape and/or Size	1	1
Pacing Inadequately	1	1
Unintended Electrical Shock	1	1
No Apparent Adverse Event	1	1
Pacing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	207	207
No Clinical Signs, Symptoms or Conditions	129	131
Blister	84	84
Itching Sensation	53	53
Rash	51	51
Skin Tears	24	24
Burn(s)	23	23
Hypersensitivity/Allergic reaction	21	21
Erythema	19	19
Burning Sensation	16	16
Skin Burning Sensation	12	12
Insufficient Information	11	12
Localized Skin Lesion	10	10
Partial thickness (Second Degree) Burn	9	9
Pain	9	9
Superficial (First Degree) Burn	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Peeling	8	8
Full thickness (Third Degree) Burn	7	7
Swelling/ Edema	6	6
Bruise/Contusion	5	5
Skin Discoloration	5	5
Hemorrhage/Bleeding	4	4
Skin Infection	4	4
Contact Dermatitis	4	4
Caustic/Chemical Burns	3	3
Unspecified Tissue Injury	3	3
Asystole	3	3
Scar Tissue	3	3
Discomfort	3	3
Skin Erosion	3	3
Abrasion	3	3
Urticaria	3	3
Ventricular Fibrillation	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Cardiac Arrest	2	2
Ecchymosis	2	2
Fall	2	2
Anaphylactoid	2	2
Local Reaction	2	2
Fluid Discharge	2	2
Purulent Discharge	2	2
Anaphylactic Shock	2	2
Asthma	2	2
Inflammation	2	2
Sore Throat	2	2
Airway Obstruction	2	2
Reaction to Medicinal Component of Device	1	1
Dyspnea	1	1

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