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	192	192
Biocompatibility	155	155
Insufficient Information	47	47
Connection Problem	41	41
Patient-Device Incompatibility	24	24
Patient Device Interaction Problem	14	14
Human-Device Interface Problem	14	14
Fitting Problem	12	12
Failure to Sense	11	11
Use of Device Problem	10	10
Loose or Intermittent Connection	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Failure to Deliver Shock/Stimulation	8	8
Device Sensing Problem	7	7
Defective Device	6	7
Loss of or Failure to Bond	6	6
Disconnection	5	5
Product Quality Problem	5	5
Appropriate Term/Code Not Available	5	5
Overheating of Device	4	4
Material Integrity Problem	4	4
Detachment of Device or Device Component	4	4
Failure to Read Input Signal	4	4
Defective Component	4	5
Improper or Incorrect Procedure or Method	4	4
Incorrect Interpretation of Signal	3	3
Electrical /Electronic Property Problem	3	3
Entrapment of Device	3	3
Output Problem	3	3
Difficult to Remove	2	2
Physical Resistance/Sticking	2	2
Signal Artifact/Noise	2	2
Unable to Obtain Readings	2	2
Failure to Transmit Record	2	2
Material Separation	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defibrillation/Stimulation Problem	2	2
Peeled/Delaminated	2	2
Adhesive Too Strong	1	1
Mechanical Problem	1	1
Poor Visibility	1	1
Unclear Information	1	1
Pacing Inadequately	1	1
Pacing Problem	1	1
No Apparent Adverse Event	1	1
Image Display Error/Artifact	1	2
Unintended Electrical Shock	1	1
Gel Leak	1	1
Material Frayed	1	1
Positioning Failure	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	303	303
No Clinical Signs, Symptoms or Conditions	134	136
Blister	109	109
Itching Sensation	76	76
Rash	64	64
Erythema	39	39
Burning Sensation	37	37
Burn(s)	28	28
Hypersensitivity/Allergic reaction	24	24
Skin Tears	24	24
Pain	14	14
Skin Burning Sensation	12	12
Insufficient Information	11	12
Partial thickness (Second Degree) Burn	10	10
Localized Skin Lesion	10	10
Peeling	9	9
Superficial (First Degree) Burn	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Full thickness (Third Degree) Burn	7	7
Swelling/ Edema	6	6
Skin Infection	5	5
Bruise/Contusion	5	5
Skin Discoloration	5	5
Hemorrhage/Bleeding	4	4
Caustic/Chemical Burns	4	4
Skin Disorders	4	4
Contact Dermatitis	4	4
Urticaria	3	3
Sore Throat	3	3
Abrasion	3	3
Unspecified Tissue Injury	3	3
Anaphylactic Shock	3	3
Skin Erosion	3	3
Asystole	3	3
Foreign Body In Patient	3	3
Discomfort	3	3
Scar Tissue	3	3
Airway Obstruction	2	2
Fluid Discharge	2	2
Fall	2	2
Ecchymosis	2	2
Chest Pain	2	2
Ventricular Fibrillation	2	2
Cardiac Arrest	2	2
Anaphylactoid	2	2
Local Reaction	2	2
Purulent Discharge	2	2
Asthma	2	2
Inflammation	2	2
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