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
2018	14	14
2019	11	11
2020	1	1
2021	7	7
2022	8	8
2023	5	5

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	17	17
No Clinical Signs, Symptoms or Conditions	10	10
Skin Tears	5	5
Burn(s)	3	3
Superficial (First Degree) Burn	3	3
Insufficient Information	3	3
Cardiac Arrest	2	2
Death	1	1
Erythema	1	1
Itching Sensation	1	1
Burn, Thermal	1	1
No Patient Involvement	1	1
Abrasion	1	1
Atrial Fibrillation	1	1
Partial thickness (Second Degree) Burn	1	1
Shock from Patient Lead(s)	1	1
No Information	1	1
Respiratory Arrest	1	1
Unspecified Respiratory Problem	1	1
Blister	1	1
Skin Burning Sensation	1	1