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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeMVK
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
6 4 8 10 6 7 15 15 12 8 22 14 14 6 17 4

MDR Year MDR Reports MDR Events
2014 5086 5086
2015 8414 8414
2016 9463 9463
2017 10853 10853
2018 9941 9941
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
Inappropriate/Inadequate Shock/Stimulation 13238 13238
Failure to Power Up 12542 12542
Device Displays Incorrect Message 10309 10309
Battery Problem 8360 8360
Adverse Event Without Identified Device or Use Problem 7460 7460
Signal Artifact/Noise 5914 5914
Break 5639 5639
Device Operates Differently Than Expected 4881 4881
Failure to Charge 3396 3396
Patient-Device Incompatibility 3353 3353
Device Inoperable 3271 3271
Protective Measures Problem 3012 3012
Charging Problem 2607 2607
Failure of Device to Self-Test 2524 2524
Display or Visual Feedback Problem 2245 2245
Defective Component 2054 2054
Over-Sensing 1911 1911
Use of Device Problem 1854 1854
Communication or Transmission Problem 1835 1835
Patient Device Interaction Problem 1809 1809
Defective Device 1780 1780
Structural Problem 1704 1704
Circuit Failure 1672 1672
Insufficient Information 1631 1631
Therapeutic or Diagnostic Output Failure 1622 1622
Inappropriate or Unexpected Reset 1553 1553
Key or Button Unresponsive/not Working 1506 1506
Reset Problem 1319 1319
Incorrect Interpretation of Signal 1244 1244
Device Sensing Problem 1204 1204
Contamination /Decontamination Problem 926 926
Output Problem 867 867
Device Alarm System 809 809
Incorrect, Inadequate or Imprecise Result or Readings 762 762
Electrical /Electronic Property Problem 588 588
Appropriate Term/Code Not Available 552 552
Connection Problem 290 290
Noise, Audible 285 285
Improper or Incorrect Procedure or Method 239 239
Scratched Material 215 215
Loss of Power 171 171
Inadequacy of Device Shape and/or Size 169 169
Failure to Sense 168 168
Device Slipped 155 155
Defective Alarm 142 142
Unable to Obtain Readings 128 128
Invalid Sensing 128 128
False Alarm 114 114
Cut In Material 102 102
Unexpected Shutdown 102 102
Material Split, Cut or Torn 100 100
Material Protrusion/Extrusion 91 91
Failure to Read Input Signal 91 91
Mechanical Problem 88 88
Power Problem 75 75
Loose or Intermittent Connection 71 71
No Display/Image 70 70
Material Integrity Problem 65 65
Output below Specifications 65 65
Defibrillation/Stimulation Problem 62 62
Device Stops Intermittently 58 58
Gel Leak 57 57
Inaccurate Delivery 56 56
Activation Failure 53 53
False Reading From Device Non-Compliance 51 51
Fitting Problem 51 51
Failure to Convert Rhythm 50 50
Physical Property Issue 43 43
Detachment of Device or Device Component 43 43
Premature Discharge of Battery 41 41
Failure to Deliver Shock/Stimulation 41 41
Activation Problem 39 39
Compatibility Problem 38 38
Image Display Error/Artifact 37 37
Unexpected Therapeutic Results 36 36
Physical Resistance/Sticking 35 35
Computer Operating System Problem 35 35
Device Fell 34 34
Leak/Splash 34 34
Contamination 34 34
Overheating of Device 33 33
Improper Device Output 33 33
Biocompatibility 32 32
Disconnection 32 32
Difficult or Delayed Activation 31 31
Bent 30 30
High impedance 29 29
Component Missing 27 27
Self-Activation or Keying 25 25
Application Interface Becomes Non-Functional Or Program Exits Abnormally 25 25
Intermittent Continuity 24 24
No Device Output 24 24
Energy Output Problem 24 24
Positioning Problem 23 23
Activation, Positioning or Separation Problem 21 21
Malposition of Device 20 20
Detachment Of Device Component 20 20
False Positive Result 20 20
Device Emits Odor 18 18
Failure to Run on Battery 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42038 42038
No Clinical Signs, Symptoms or Conditions 19060 19060
Insufficient Information 13563 13563
Shock from Patient Lead(s) 8471 8471
Skin Irritation 5801 5801
Skin Inflammation/ Irritation 5195 5195
Arrhythmia 2976 2978
Death 2138 2138
Rash 1976 1976
Atrial Fibrillation 1712 1713
Electric Shock 1210 1210
No Information 1168 1168
Shock 781 781
Tachycardia 576 576
No Code Available 517 517
Irritation 459 459
Itching Sensation 431 431
Loss of consciousness 431 431
Asystole 407 407
Ventricular Fibrillation 383 383
Ventricular Tachycardia 345 345
Bradycardia 302 302
Abrasion 229 229
Erythema 213 213
Fall 201 201
Asystole 139 139
Idioventricular Rhythm 128 128
Hemorrhage/Bleeding 128 128
Unspecified Infection 122 122
Cardiac Arrest 120 120
Atrial Flutter 111 111
No Consequences Or Impact To Patient 100 100
Pressure Sores 95 95
Blister 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 87 87
Pain 83 83
Dizziness 82 82
Burn(s) 81 81
Bruise/Contusion 80 80
Swelling 79 79
Skin Disorders 78 78
Bleeding 69 69
Hypersensitivity/Allergic reaction 64 64
Injury 62 62
No Patient Involvement 58 58
Fungal Infection 44 44
Reaction 42 42
Burning Sensation 41 41
Laceration(s) 39 39
Fluid Discharge 39 39
Patient Problem/Medical Problem 35 35
Tissue Breakdown 35 35
Confusion/ Disorientation 35 35
Dyspnea 35 35
Superficial (First Degree) Burn 32 32
Burn, Thermal 30 31
Complaint, Ill-Defined 29 29
Scar Tissue 27 27
Chest Pain 26 26
Seizures 23 23
Skin Discoloration 23 23
Sudden Cardiac Death 23 23
Skin Burning Sensation 21 21
Localized Skin Lesion 21 21
Skin Tears 20 20
Tissue Damage 19 19
Cardiopulmonary Arrest 19 19
Cognitive Changes 18 18
Partial thickness (Second Degree) Burn 17 17
Sweating 17 17
Bone Fracture(s) 17 17
Head Injury 16 16
Blister(s) 16 16
Weakness 16 16
Collapse 16 16
Heart Block 16 16
Discharge 15 15
Ulcer 15 15
Urticaria 14 14
Loss Of Pulse 14 14
Lead(s), Burn(s) From 13 13
Discomfort 13 13
Allergic reaction 13 13
Syncope 13 13
Purulent Discharge 13 13
Abscess 12 12
Vomiting 12 12
Scarring 11 12
Respiratory Arrest 11 11
Therapeutic Effects, Unexpected 10 10
Hip Fracture 9 9
Hyperglycemia 9 9
Blood Loss 9 9
Lethargy 8 8
Unspecified Tissue Injury 8 8
Hematoma 8 8
Headache 7 7
Bacterial Infection 7 7
Cyst(s) 7 7
Impaired Healing 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Zoll Lifecor Corporation II Dec-16-2010
2 Zoll Lifecor Corporation II Jan-28-2009
3 Zoll Manufacturing Corp. II Jan-14-2018
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