TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2017	19	19
2018	14	14
2019	11	11
2020	1	1
2021	7	7
2022	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Sense	7	7
Device Operates Differently Than Expected	6	6
Device Sensing Problem	6	6
Failure of Device to Self-Test	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Connection Problem	4	4
Appropriate Term/Code Not Available	4	4
Insufficient Information	3	3
Sparking	2	2
Arcing of Electrodes	2	2
Bent	2	2
Failure to Deliver Shock/Stimulation	2	2
Failure to Discharge	1	1
Electrical /Electronic Property Problem	1	1
Failure to Deliver Energy	1	1
Fire	1	1
Gel Leak	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Unable to Obtain Readings	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Failure to Analyze Signal	1	1
Break	1	1
Incomplete or Missing Packaging	1	1
Material Protrusion/Extrusion	1	1
Patient-Device Incompatibility	1	1
Output Problem	1	1
Protective Measures Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	27	27
No Clinical Signs, Symptoms or Conditions	8	8
Skin Tears	5	5
No Patient Involvement	4	4
Superficial (First Degree) Burn	3	3
No Information	3	3
Burn(s)	3	3
Insufficient Information	3	3
Cardiac Arrest	2	2
Death	2	2
Erythema	1	1
Itching Sensation	1	1
Burn, Thermal	1	1
Abrasion	1	1
Atrial Fibrillation	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Unspecified Respiratory Problem	1	1
Blister	1	1
Skin Burning Sensation	1	1
Partial thickness (Second Degree) Burn	1	1