• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2019 2020 2021 2022 2023 2024
22 14 14 6 17 5

MDR Year MDR Reports MDR Events
2019 9894 9894
2020 11904 11904
2021 12466 12466
2022 12667 12667
2023 12988 12988
2024 4432 4432

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 8695 8695
Battery Problem 8260 8260
Inappropriate/Inadequate Shock/Stimulation 6692 6692
Adverse Event Without Identified Device or Use Problem 5320 5320
Break 3319 3319
Protective Measures Problem 2959 2959
Signal Artifact/Noise 2540 2540
Failure of Device to Self-Test 2105 2105
Patient Device Interaction Problem 1968 1968
Device Displays Incorrect Message 1960 1960
Defective Component 1955 1955
Failure to Charge 1876 1876
Circuit Failure 1860 1860
Structural Problem 1747 1747
Display or Visual Feedback Problem 1719 1719
Charging Problem 1645 1645
Key or Button Unresponsive/not Working 1615 1615
Therapeutic or Diagnostic Output Failure 1602 1602
Defective Device 1483 1483
Over-Sensing 1413 1413
Incorrect Interpretation of Signal 1302 1302
Patient-Device Incompatibility 1300 1300
Contamination /Decontamination Problem 999 999
Use of Device Problem 824 824
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
Failure to Convert Rhythm 46 46
Power Problem 46 46
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 19731 19731
Insufficient Information 13564 13564
No Known Impact Or Consequence To Patient 12997 12997
Shock from Patient Lead(s) 5941 5941
Skin Inflammation/ Irritation 5357 5357
Arrhythmia 2335 2336
Skin Irritation 1951 1951
Death 920 920
Atrial Fibrillation 839 839
Rash 566 566
Asystole 408 408
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 99 99
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
Burn(s) 34 34
Burning Sensation 31 31
Superficial (First Degree) Burn 31 31
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
Skin Tears 18 18
Reaction 18 18
Laceration(s) 18 18
Unspecified Infection 17 17
Atrial Flutter 16 16
Fungal Infection 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
Head Injury 9 9
Scar Tissue 9 9
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

-
-