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 Systems
Address: 22100 Bothell Everett Hwy, Bothell, WA 98021
Approval Date: June 6, 2019
Approval Letter: Approval Order
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 defibrillators use two (2) multifunction defibrillation electrodes, placed on the patient’s chest, to get a patient’s electrical activity of the heart electrocardiogram (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? 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? 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) :