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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device over-the-counter automated external defibrillator
Definition Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
Product CodeNSA
Regulation Number 870.5310
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
2 4 6 5 4 3

MDR Year MDR Reports MDR Events
2019 55 55
2020 39 39
2021 20 20
2022 23 23
2023 67 67
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 69 69
Failure to Power Up 57 57
Incorrect, Inadequate or Imprecise Result or Readings 38 38
No Audible Prompt/Feedback 23 23
Inappropriate Audible Prompt/Feedback 12 12
Audible Prompt/Feedback Problem 10 10
Failure to Deliver Shock/Stimulation 9 9
Electrical /Electronic Property Problem 6 6
Key or Button Unresponsive/not Working 6 6
Unexpected Shutdown 5 5
Nonstandard Device 4 4
Failure to Deliver Energy 3 3
Insufficient Information 3 3
Defective Device 3 3
Appropriate Term/Code Not Available 3 3
Failure to Sense 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defibrillation/Stimulation Problem 2 2
Device Sensing Problem 2 2
Protective Measures Problem 2 2
No Visual Prompts/Feedback 2 2
Battery Problem 2 2
Failure to Analyze Signal 2 2
Difficult or Delayed Activation 1 1
Device Difficult to Setup or Prepare 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Power Problem 1 1
Connection Problem 1 1
Intermittent Loss of Power 1 1
Display or Visual Feedback Problem 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Output Problem 1 1
Program or Algorithm Execution Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 170 170
No Known Impact Or Consequence To Patient 80 80
Insufficient Information 14 14
Death 1 1
Cardiac Arrest 1 1
Ventricular Fibrillation 1 1
No Patient Involvement 1 1

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