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	2

MDR Year	MDR Reports	MDR Events
2021	12466	12466
2022	12667	12667
2023	12988	12988
2024	12585	12585
2025	12292	12292
2026	1003	1003

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	13173	13173
Failure to Power Up	6931	6931
Circuit Failure	6230	6230
Patient Device Interaction Problem	5363	5363
Inappropriate/Inadequate Shock/Stimulation	4431	4431
Adverse Event Without Identified Device or Use Problem	3312	3312
Incorrect Interpretation of Signal	3264	3264
Key or Button Unresponsive/not Working	3136	3136
Structural Problem	2725	2725
Charging Problem	2500	2500
Contamination /Decontamination Problem	2493	2493
Over-Sensing	2160	2160
Signal Artifact/Noise	1679	1679
Defective Component	1408	1408
Break	1368	1368
Protective Measures Problem	915	915
Failure of Device to Self-Test	902	902
Failure to Charge	891	891
Display or Visual Feedback Problem	804	804
Use of Device Problem	736	736
Electrical /Electronic Property Problem	712	712
Device Displays Incorrect Message	688	688
Output Problem	568	568
Defective Device	512	512
Patient-Device Incompatibility	496	496
Communication or Transmission Problem	432	432
Therapeutic or Diagnostic Output Failure	403	403
Inappropriate or Unexpected Reset	206	206
Device Sensing Problem	196	196
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	95	95
Connection Problem	90	90
Inadequacy of Device Shape and/or Size	70	70
Defective Alarm	56	56
Unexpected Shutdown	56	56
Insufficient Information	55	55
Activation Failure	44	44
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
Mechanical Problem	22	22
Output below Specifications	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	33921	33921
Insufficient Information	11411	11411
Skin Inflammation/ Irritation	8295	8295
Arrhythmia	5522	5522
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	56	56
Hemorrhage/Bleeding	52	52
Burn(s)	45	45
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
Heart Block	15	15
Multiple Fractures	15	15
Skin Tears	15	15
Dizziness	14	14
Skin Irritation	13	13
Ventricular Tachycardia	13	13
Head Injury	12	12
Tissue Breakdown	11	11
Skin Discoloration	11	11
Abrasion	11	11
Pressure Sores	11	11
Urticaria	10	10
Fungal Infection	10	10
Respiratory Arrest	10	10
Unspecified Infection	9	9
Shock	9	9
Unspecified Tissue Injury	8	8