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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 2 4 6 5 4 3

MDR Year MDR Reports MDR Events
2014 177 177
2015 62 62
2016 44 44
2017 56 56
2018 69 69
2019 55 55
2020 39 39
2021 20 20
2022 23 23
2023 67 67
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 271 271
Failure of Device to Self-Test 156 156
Failure to Power Up 47 47
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Inappropriate Audible Prompt/Feedback 12 12
Failure to Deliver Shock/Stimulation 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Appropriate Term/Code Not Available 9 9
Audible Prompt/Feedback Problem 9 9
Device Displays Incorrect Message 8 8
Nonstandard Device 6 6
Insufficient Information 6 6
Key or Button Unresponsive/not Working 5 5
Electrical /Electronic Property Problem 5 5
No Audible Prompt/Feedback 5 5
Defective Device 5 5
Battery Problem 4 4
Noise, Audible 4 4
Unexpected Shutdown 3 3
Protective Measures Problem 3 3
Device Sensing Problem 3 3
Failure to Deliver Energy 3 3
Failure to Analyze Signal 2 2
Self-Activation or Keying 2 2
Failure to Sense 2 2
Defibrillation/Stimulation Problem 2 2
Device Inoperable 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Visual Prompts/Feedback 2 2
Output Problem 1 1
Power Problem 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Device Packaging Compromised 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Out-Of-Box Failure 1 1
Display or Visual Feedback Problem 1 1
Computer Software Problem 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 431 431
No Clinical Signs, Symptoms or Conditions 127 127
No Information 30 30
No Consequences Or Impact To Patient 18 18
Insufficient Information 14 14
No Patient Involvement 5 5
Death 5 5
Hemorrhage, Cerebral 1 1
Ventricular Fibrillation 1 1
Partial thickness (Second Degree) Burn 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips Medical Systems II Mar-23-2010
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