Over-The-Counter Automated External Defibrillator
FDA adverse event reports and recall history for over-the-counter automated external defibrillator (product code NSA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,742
- Deaths
- 30
- Injuries
- 15
- Malfunctions
- 1,696
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-03-23TerminatedNonconforming Material/Component
Heartstart HS1 Defibrillator Model M5068A
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- 2008-07-09TerminatedComponent design/selection
Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
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