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)
2019	2020	2021	2022	2023	2024
22	14	14	6	17	4

MDR Year	MDR Reports	MDR Events
2019	9894	9894
2020	11904	11904
2021	12466	12466
2022	12667	12667
2023	12988	12988
2024	3433	3433

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Power Up	8695	8695
Battery Problem	8043	8043
Inappropriate/Inadequate Shock/Stimulation	6688	6688
Adverse Event Without Identified Device or Use Problem	5312	5312
Break	3319	3319
Protective Measures Problem	2959	2959
Signal Artifact/Noise	2537	2537
Failure of Device to Self-Test	2105	2105
Device Displays Incorrect Message	1960	1960
Defective Component	1955	1955
Failure to Charge	1876	1876
Patient Device Interaction Problem	1808	1808
Display or Visual Feedback Problem	1719	1719
Structural Problem	1684	1684
Circuit Failure	1672	1672
Therapeutic or Diagnostic Output Failure	1602	1602
Charging Problem	1583	1583
Key or Button Unresponsive/not Working	1506	1506
Defective Device	1483	1483
Over-Sensing	1339	1339
Patient-Device Incompatibility	1298	1298
Incorrect Interpretation of Signal	1209	1209
Contamination /Decontamination Problem	925	925
Use of Device Problem	823	823
Output Problem	823	823
Incorrect, Inadequate or Imprecise Result or Readings	743	743
Communication or Transmission Problem	715	715
Device Alarm System	577	577
Electrical /Electronic Property Problem	554	554
Inappropriate or Unexpected Reset	470	470
Device Sensing Problem	414	414
Reset Problem	328	328
Appropriate Term/Code Not Available	231	231
Connection Problem	141	141
Unable to Obtain Readings	126	126
Inadequacy of Device Shape and/or Size	119	119
Defective Alarm	118	118
Unexpected Shutdown	102	102
Insufficient Information	92	92
Material Split, Cut or Torn	89	89
Scratched Material	68	68
Failure to Sense	60	60
Device Slipped	56	56
Activation Failure	50	50
Noise, Audible	47	47
Loss of Power	47	47
Power Problem	46	46
Failure to Convert Rhythm	43	43
Material Integrity Problem	42	42
Output below Specifications	41	41
Detachment of Device or Device Component	41	41
Failure to Read Input Signal	37	37
Loose or Intermittent Connection	36	36
Activation Problem	36	36
Mechanical Problem	35	35
Premature Discharge of Battery	34	34
Failure to Deliver Shock/Stimulation	33	33
Device Fell	33	33
Inaccurate Delivery	32	32
Computer Operating System Problem	29	29
Physical Resistance/Sticking	28	28
Improper or Incorrect Procedure or Method	27	27
Gel Leak	27	27
No Display/Image	25	25
Material Protrusion/Extrusion	23	23
Image Display Error/Artifact	20	20
Energy Output Problem	18	18
Failure to Run on Battery	18	18
Defibrillation/Stimulation Problem	18	18
Fitting Problem	17	17
Overheating of Device	17	17
False Alarm	17	17
Low Sensing Threshold	15	15
Difficult or Delayed Activation	15	15
Activation, Positioning or Separation Problem	15	15
Contamination	14	14
Compatibility Problem	14	14
Component Missing	13	13
Misconnection	11	11
Intermittent Loss of Power	11	11
Incomplete or Inadequate Connection	10	10
Wireless Communication Problem	10	10
No Device Output	10	10
False Positive Result	10	10
Self-Activation or Keying	10	10
Operating System Becomes Nonfunctional	9	9
Application Program Problem	8	8
High Sensing Threshold	8	8
Disconnection	8	8
Thermal Decomposition of Device	8	8
Failure to Analyze Signal	8	8
Pacing Problem	7	7
Positioning Problem	7	7
Temperature Problem	6	6
No Audible Alarm	6	6
Unintended Ejection	6	6
Electrical Shorting	6	6
Smoking	5	5
Fire	5	5
Corroded	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19060	19060
Insufficient Information	13563	13563
No Known Impact Or Consequence To Patient	12997	12997
Shock from Patient Lead(s)	5941	5941
Skin Inflammation/ Irritation	5195	5195
Arrhythmia	2168	2169
Skin Irritation	1951	1951
Death	920	920
Atrial Fibrillation	839	839
Rash	566	566
Asystole	407	407
Electric Shock	397	397
Itching Sensation	382	382
Tachycardia	341	341
Loss of consciousness	261	261
Irritation	225	225
Bradycardia	222	222
Ventricular Fibrillation	218	218
No Code Available	186	186
Erythema	173	173
Ventricular Tachycardia	127	127
Idioventricular Rhythm	122	122
Fall	98	98
Blister	87	87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	87	87
Skin Disorders	78	78
Hemorrhage/Bleeding	72	72
Dizziness	55	55
Cardiac Arrest	51	51
Pain	49	49
Swelling	49	49
Bruise/Contusion	45	45
Hypersensitivity/Allergic reaction	43	43
Shock	42	42
Burning Sensation	31	31
Superficial (First Degree) Burn	31	31
Burn(s)	30	30
Fluid Discharge	29	29
Tissue Breakdown	27	27
Pressure Sores	26	26
Dyspnea	22	22
Skin Discoloration	21	21
Burn, Thermal	21	22
Skin Burning Sensation	21	21
Localized Skin Lesion	21	21
Confusion/ Disorientation	18	18
Reaction	18	18
Laceration(s)	18	18
Unspecified Infection	17	17
Skin Tears	17	17
Fungal Infection	16	16
Atrial Flutter	16	16
Heart Block	16	16
No Patient Involvement	13	13
Abrasion	13	13
Cardiopulmonary Arrest	13	13
Chest Pain	13	13
Purulent Discharge	12	12
Urticaria	12	12
Sweating	11	11
Respiratory Arrest	11	11
No Information	10	10
Tissue Damage	10	10
Injury	10	10
Vomiting	9	9
Scar Tissue	9	9
Head Injury	8	8
Ulcer	8	8
Discomfort	8	8
Patient Problem/Medical Problem	8	8
Partial thickness (Second Degree) Burn	8	8
Unspecified Tissue Injury	8	8
Blood Loss	7	7
Loss Of Pulse	7	7
Cognitive Changes	7	7
Chills	7	7
Discharge	7	7
Syncope	7	7
Seizures	6	6
Hip Fracture	6	6
Collapse	6	6
Lethargy	6	6
Heart Failure/Congestive Heart Failure	6	6
Syncope/Fainting	6	6
Multiple Fractures	5	5
Swelling/ Edema	5	5
Palpitations	5	5
Impaired Healing	5	5
Muscle Weakness	5	5
Myocardial Infarction	5	5
Peeling	5	5
Abscess	5	5
Headache	5	5
Bone Fracture(s)	5	5
Fatigue	4	4
Hematoma	4	4
Cyst(s)	4	4
Weakness	4	4
Malaise	4	4
Diaphoresis	4	4