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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)
2017 2018 2019 2020 2021 2022
0 0 2 4 6 5

MDR Year MDR Reports MDR Events
2017 56 56
2018 69 69
2019 55 55
2020 39 39
2021 20 20
2022 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 100 100
Device Operates Differently Than Expected 55 55
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Appropriate Term/Code Not Available 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 6 6
Nonstandard Device 6 6
Failure to Power Up 6 6
Defective Device 5 5
Device Displays Incorrect Message 3 3
Inappropriate Audible Prompt/Feedback 3 3
Battery Problem 2 2
Failure to Deliver Shock/Stimulation 2 2
Electrical /Electronic Property Problem 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 1 1
Computer Software Problem 1 1
Audible Prompt/Feedback Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Analyze Signal 1 1
Failure to Sense 1 1
Defibrillation/Stimulation Problem 1 1
Use of Device Problem 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Out-Of-Box Failure 1 1
Device Packaging Compromised 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 193 193
No Clinical Signs, Symptoms or Conditions 32 32
Insufficient Information 14 14
No Information 8 8
No Patient Involvement 5 5
Death 1 1

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