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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
Regulation Description Automated external defibrillator system.
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 0

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

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 Resultor Readings 39 39
Appropriate Term/Code Not Available 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Nonstandard Device 6 6
Insufficient Information 6 6
Defective Device 5 5
Device Displays Incorrect Message 3 3
Battery Problem 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 1 1
Device Packaging Compromised 1 1
Mechanics Altered 1 1
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Computer Software Problem 1 1
Failure to Deliver Shock/Stimulation 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 18 18
Insufficient Information 14 14
No Information 8 8
No Patient Involvement 5 5
Death 1 1

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