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)
2020	2021	2022	2023	2024	2025
14	14	6	17	21	4

MDR Year	MDR Reports	MDR Events
2020	11904	11904
2021	12466	12466
2022	12667	12667
2023	12988	12988
2024	12585	12585
2025	4290	4290

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	11625	11625
Failure to Power Up	7945	7945
Inappropriate/Inadequate Shock/Stimulation	5679	5679
Adverse Event Without Identified Device or Use Problem	4508	4508
Circuit Failure	4424	4424
Patient Device Interaction Problem	3928	3928
Key or Button Unresponsive/not Working	2548	2548
Incorrect Interpretation of Signal	2475	2475
Break	2400	2400
Structural Problem	2320	2320
Signal Artifact/Noise	2145	2145
Protective Measures Problem	2110	2110
Over-Sensing	1930	1930
Charging Problem	1912	1912
Contamination /Decontamination Problem	1792	1792
Failure of Device to Self-Test	1780	1780
Defective Component	1707	1707
Failure to Charge	1457	1457
Device Displays Incorrect Message	1302	1302
Therapeutic or Diagnostic Output Failure	1127	1127
Display or Visual Feedback Problem	1077	1077
Defective Device	1019	1019
Patient-Device Incompatibility	787	787
Use of Device Problem	778	778
Output Problem	664	664
Electrical /Electronic Property Problem	621	621
Communication or Transmission Problem	575	575
Device Alarm System	388	388
Incorrect, Inadequate or Imprecise Result or Readings	387	387
Inappropriate or Unexpected Reset	350	350
Device Sensing Problem	260	260
Reset Problem	216	216
Appropriate Term/Code Not Available	141	141
Unable to Obtain Readings	125	125
Connection Problem	104	104
Inadequacy of Device Shape and/or Size	104	104
Unexpected Shutdown	94	94
Defective Alarm	91	91
Failure to Convert Rhythm	77	77
Insufficient Information	69	69
Failure to Sense	50	50
Material Split, Cut or Torn	47	47
Activation Failure	44	44
Material Integrity Problem	40	40
Power Problem	39	39
Detachment of Device or Device Component	37	37
Output below Specifications	34	34
Premature Discharge of Battery	33	33
Device Fell	31	31
Failure to Read Input Signal	31	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	28315	28315
Insufficient Information	13576	13576
Skin Inflammation/ Irritation	7326	7326
No Known Impact Or Consequence To Patient	5857	5857
Shock from Patient Lead(s)	5180	5180
Arrhythmia	4194	4195
Skin Irritation	892	892
Atrial Fibrillation	724	724
Death	580	580
Rash	481	481
Asystole	412	412
Tachycardia	324	324
Itching Sensation	311	311
Electric Shock	256	256
Loss of consciousness	213	213
Ventricular Fibrillation	204	204
Bradycardia	196	196
Erythema	152	152
Idioventricular Rhythm	121	121
Blister	90	90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	87	87
Ventricular Tachycardia	85	85
No Code Available	83	83
Skin Disorders	78	78
Fall	75	75
Irritation	66	66
Hemorrhage/Bleeding	59	59
Burn(s)	45	45
Bruise/Contusion	40	40
Cardiac Arrest	39	39
Dizziness	39	39
Pain	34	34
Hypersensitivity/Allergic reaction	33	33
Superficial (First Degree) Burn	32	32
Swelling	27	27
Fluid Discharge	26	26
Burning Sensation	26	26
Shock	21	21
Localized Skin Lesion	21	21
Skin Burning Sensation	21	21
Laceration(s)	17	17
Heart Block	16	16
Skin Discoloration	16	16
Dyspnea	15	15
Skin Tears	15	15
Reaction	14	14
Pressure Sores	14	14
Tissue Breakdown	14	14
Confusion/ Disorientation	13	13
Head Injury	12	12