TPLC - Total Product Life Cycle

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Device	electrode, electrocardiograph, multi-function
Product Code	MLN
Regulation Number	870.2360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	36	36
Failure To Adhere Or Bond	21	21
Device Sensing Problem	16	16
Connection Problem	13	13
Failure of Device to Self-Test	11	11
Device Displays Incorrect Message	10	10
Failure to Sense	8	8
Sparking	6	6
Failure to Discharge	6	6
Insufficient Information	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Fire	5	5
Arcing of Electrodes	5	5
Device Dislodged or Dislocated	5	5
Communication or Transmission Problem	4	4
Arcing	4	4
Device Inoperable	4	4
Appropriate Term/Code Not Available	4	4
Device Stops Intermittently	3	3
Device Emits Odor	3	3
Loose or Intermittent Connection	3	3
Failure to Deliver Shock/Stimulation	3	3
Loss of or Failure to Bond	3	3
Fitting Problem	3	3
Bent	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Defibrillation/Stimulation Problem	2	2
Packaging Problem	2	2
Difficult to Remove	2	2
Device Alarm System	2	2
Failure to Read Input Signal	2	2
Incomplete or Missing Packaging	2	2
Patient-Device Incompatibility	2	2
Break	2	2
Device Handling Problem	1	1
Thermal Decomposition of Device	1	1
Use of Device Problem	1	1
Misconnection	1	1
Component Missing	1	1
Material Deformation	1	1
Unable to Obtain Readings	1	1
Pacing Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
No Display/Image	1	1
Protective Measures Problem	1	1
Mechanical Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Output Problem	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	94	94
No Patient Involvement	20	20
No Consequences Or Impact To Patient	18	18
Death	15	15
No Clinical Signs, Symptoms or Conditions	11	11
Burn(s)	9	9
Skin Tears	7	7
Superficial (First Degree) Burn	6	6
No Information	6	6
Cardiac Arrest	4	4
Insufficient Information	3	3
Partial thickness (Second Degree) Burn	3	3
Burn, Thermal	2	2
Ventricular Fibrillation	2	2
Injury	2	2
Full thickness (Third Degree) Burn	2	2
Fracture, Arm	1	1
Electric Shock	1	1
Skin Irritation	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Shock from Patient Lead(s)	1	1
Itching Sensation	1	1
Blister	1	1
Abrasion	1	1
Atrial Fibrillation	1	1
Erythema	1	1
Cardiopulmonary Arrest	1	1
Tissue Damage	1	1
Therapeutic Response, Decreased	1	1
Myocardial Infarction	1	1
Unspecified Respiratory Problem	1	1
Skin Burning Sensation	1	1