This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.Product Name: HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A)PMA Applicant: Philips Medical SystemsAddress: 22100 Bothell Everett Hwy, Bothell, WA 98021Approval Date: June 6, 2019Approval Letter:What is it? The HeartStart OnSite (M5066A) and HeartStart Home (M5068A) are automatic external defibrillators (AED) designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating.The HeartStart OnSite model is intended for public access defibrillation and the HeartStart Home model is intended for at-home use.How does it work? The HeartStart OnSite and HeartStart Home use two (2) multifunction defibrillation electrodes, placed on the patient’s chest, to get a patient’s electrical activity of the heart (ECG). If this device detects an abnormal heartbeat, it may advise the user that a “shock” from the defibrillator to restore the heart’s normal pumping rhythm is appropriate.

The user interface will provide voice prompts to guide the user through the rescue process including shock delivery or cardiopulmonary resuscitation (CPR). If a defibrillation shock is required, the device delivers an electrical shock to the patient through the defibrillator electrodes.When is it used?

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The Philips HeartStart FRx Defibrillator 861304 (“FRx”) is an automated external defibrillator (AED). Small, lightweight, rugged, and battery powered, it is designed for simple and reliable oper ation. 1 best-selling Philips HeartStart OnSite AED is a life-saving rescue device. With its many features and benefits, this reliable and fully self-contained unit is easy to transport at just 3.3 lbs., making the Philips HeartStart OnSite AED a must for quick access and immediate use. Why acquire a Philips HeartStart.

The OnSite model is intended for public access defibrillation and the Home model is intended for at-home use. The HeartStart OnSite model and the HeartStart Home model are used to treat potential victims of sudden cardiac arrest over 55 pounds (25 kg) with the following symptoms: unconsciousness and absence of normal breathing. The models may also be used with the optional Infant/Child SMART Pads (Model M5072A) on children under 55 pounds (25 kg) or 8 years old. If Infant/Child SMART pads are not available, or you are uncertain of the child’s age or weight, proceed with treatment using adult SMART pads (Model M5071A).Both models are intended for use by minimally trained users (laypersons) in order to initiate the rescue process until emergency medical services (EMS) or other first responders arrive.What will it accomplish?

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The combination of CPR and early defibrillation is highly effective in saving patient lives when used in in the first few minutes following collapse from sudden cardiac arrest. For every minute that passes between collapse and defibrillation, survival rates from SCA decrease by 7-10%.

Use of the HeartStart OnSite and HeartStart Home devices can reduce the time in cardiac arrest and increase the chance of patient survival.When should it not be used? The HeartStart OnSite and HeartStart Home defibrillators should not be used when a patient is conscious and breathing normally.Additional information (including warnings, precautions, and adverse events):.

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The Philips HeartStart FRx device takes what is great about the Philips OnSite and builds on it. Not only is it easy to use and lightweight, it also adds some unique features, like the ability for the device to be used on an infant with the insertion of a key. This device can also be used as a training device, which will save money in the long run. The FRx is one of the most popular mid-tier devices on the market for good reason: high functionality and a robust feature set. Reviewed by:Alternate Part Number(s): 861304, 861304-C01, 861304-CO1, 861304-C03, 861304-CO3, 861304-RO1, 861304-R01, 861304-RO2, 861304-R02, 861304-YC. A customer fainted in our business with never having done so before. He awoke before 911 was dispatched.

In talking with him and others I learned that if the heart stops beating for only a few seconds fainting can occur. This incident got me to thinking that as a responsible business owner that we should be prepared in the event that we might have an opportunity to save a life. We purchased two units,one of which is business the other for home. Our neighbors have been informed that a AED is available to them as/if needed. PS: Our local fire department told me that they only carry Phillips AED's on all equipment.