TPLC - Total Product Life Cycle

• Device: wearable automated external defibrillator
• Definition: The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
• Product Code: MVK
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
14	6	17	21	15	6

MDR Year	MDR Reports	MDR Events
2021	12466	12466
2022	12667	12667
2023	12988	12988
2024	12585	12585
2025	12292	12292
2026	5100	5100

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	13830	13830
Circuit Failure	7134	7134
Failure to Power Up	6952	6952
Patient Device Interaction Problem	6005	6005
Inappropriate/Inadequate Shock/Stimulation	4504	4504
Incorrect Interpretation of Signal	3676	3676
Key or Button Unresponsive/not Working	3534	3534
Adverse Event Without Identified Device or Use Problem	3334	3334
Structural Problem	2896	2896
Charging Problem	2861	2861
Contamination /Decontamination Problem	2776	2776
Over-Sensing	2378	2378
Signal Artifact/Noise	1692	1692
Defective Component	1408	1408
Break	1368	1368
Protective Measures Problem	915	915
Failure of Device to Self-Test	902	902
Failure to Charge	892	892
Use of Device Problem	810	810
Display or Visual Feedback Problem	804	804
Electrical /Electronic Property Problem	777	777
Device Displays Incorrect Message	688	688
Output Problem	568	568
Defective Device	512	512
Patient-Device Incompatibility	502	502
Communication or Transmission Problem	484	484
Therapeutic or Diagnostic Output Failure	403	403
Inappropriate or Unexpected Reset	206	206
Device Sensing Problem	197	197
Reset Problem	158	158
Unable to Obtain Readings	125	125
Incorrect, Inadequate or Imprecise Result or Readings	123	123
Device Alarm System	107	107
Appropriate Term/Code Not Available	104	104
Failure to Convert Rhythm	103	103
Connection Problem	90	90
Inadequacy of Device Shape and/or Size	70	70
Defective Alarm	56	56
Unexpected Shutdown	56	56
Insufficient Information	56	56
Activation Failure	45	45
Failure to Sense	43	43
Material Integrity Problem	38	38
Power Problem	33	33
Detachment of Device or Device Component	30	30
Premature Discharge of Battery	30	30
Device Fell	29	29
Failure to Read Input Signal	28	28
No Apparent Adverse Event	26	26
Mechanical Problem	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36718	36718
Insufficient Information	11416	11416
Skin Inflammation/ Irritation	8936	8936
Arrhythmia	6187	6187
Shock from Patient Lead(s)	3961	3961
Atrial Fibrillation	595	595
Rash	422	422
Asystole	411	411
Tachycardia	310	310
Itching Sensation	241	241
Ventricular Fibrillation	170	170
Electric Shock	168	168
Bradycardia	158	158
Loss of consciousness	154	154
Idioventricular Rhythm	121	121
Erythema	114	114
Blister	91	91
Death	84	84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	82	82
Skin Disorders	78	78
Fall	61	61
Hemorrhage/Bleeding	52	52
Burn(s)	47	47
Bruise/Contusion	34	34
Superficial (First Degree) Burn	32	32
Hypersensitivity/Allergic reaction	30	30
Pain	26	26
Fluid Discharge	24	24
Skin Burning Sensation	21	21
Localized Skin Lesion	21	21
Burning Sensation	20	20
Cardiac Arrest	18	18
Laceration(s)	16	16
Multiple Fractures	16	16
Heart Block	15	15
Skin Tears	15	15
Dizziness	14	14
Head Injury	14	14
Skin Irritation	13	13
Ventricular Tachycardia	13	13
Abrasion	13	13
Pressure Sores	11	11
Skin Discoloration	11	11
Tissue Breakdown	11	11
Urticaria	10	10
Fungal Infection	10	10
Respiratory Arrest	10	10
Bone Fracture(s)	9	9
Unspecified Infection	9	9
Shock	9	9