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	20

MDR Year	MDR Reports	MDR Events
2019	9894	9894
2020	11904	11904
2021	12466	12466
2022	12667	12667
2023	12988	12988
2024	10644	10644

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	10258	10258
Failure to Power Up	8708	8708
Inappropriate/Inadequate Shock/Stimulation	6734	6734
Adverse Event Without Identified Device or Use Problem	5356	5356
Break	3319	3319
Protective Measures Problem	2959	2959
Circuit Failure	2939	2939
Patient Device Interaction Problem	2909	2909
Signal Artifact/Noise	2563	2563
Structural Problem	2119	2119
Failure of Device to Self-Test	2105	2105
Key or Button Unresponsive/not Working	2090	2090
Device Displays Incorrect Message	1960	1960
Defective Component	1955	1955
Charging Problem	1881	1881
Failure to Charge	1877	1877
Incorrect Interpretation of Signal	1821	1821
Display or Visual Feedback Problem	1719	1719
Over-Sensing	1670	1670
Therapeutic or Diagnostic Output Failure	1602	1602
Defective Device	1483	1483
Contamination /Decontamination Problem	1394	1394
Patient-Device Incompatibility	1311	1311
Use of Device Problem	853	853
Output Problem	823	823
Incorrect, Inadequate or Imprecise Result or Readings	743	743
Communication or Transmission Problem	715	715
Electrical /Electronic Property Problem	584	584
Device Alarm System	577	577
Inappropriate or Unexpected Reset	470	470
Device Sensing Problem	414	414
Reset Problem	328	328
Appropriate Term/Code Not Available	231	231
Connection Problem	143	143
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
Failure to Convert Rhythm	59	59
Device Slipped	56	56
Activation Failure	50	50
Loss of Power	47	47
Noise, Audible	47	47
Power Problem	46	46
Material Integrity Problem	42	42
Detachment of Device or Device Component	41	41

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24145	24145
Insufficient Information	13570	13570
No Known Impact Or Consequence To Patient	12997	12997
Skin Inflammation/ Irritation	6302	6302
Shock from Patient Lead(s)	5968	5968
Arrhythmia	3160	3161
Skin Irritation	1951	1951
Death	920	920
Atrial Fibrillation	839	839
Rash	566	566
Asystole	411	411
Electric Shock	398	398
Itching Sensation	383	383
Tachycardia	342	342
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	101	101
Blister	90	90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	87	87
Skin Disorders	78	78
Hemorrhage/Bleeding	72	72
Dizziness	55	55
Cardiac Arrest	52	52
Pain	49	49
Swelling	49	49
Bruise/Contusion	45	45
Hypersensitivity/Allergic reaction	44	44
Shock	42	42
Burn(s)	40	40
Burning Sensation	31	31
Superficial (First Degree) Burn	31	31
Fluid Discharge	29	29
Tissue Breakdown	27	27
Pressure Sores	26	26
Dyspnea	23	23
Burn, Thermal	21	22
Localized Skin Lesion	21	21
Skin Discoloration	21	21
Skin Burning Sensation	21	21
Laceration(s)	18	18
Skin Tears	18	18
Confusion/ Disorientation	18	18
Reaction	18	18
Unspecified Infection	17	17