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: Philips HeartStart FR3 Defibrillator and Accessories
PMA Applicant: Philips Medical Systems
Address: 22100 Bothell Everett Hwy, Bothell, WA 98021
Approval Date: May 11, 2020
Approval Letter: Approval Order

What is it? The HeartStart FR3 Defibrillator is a battery-powered automated external defibrillator (AED). The HeartStart FR3 AED is indicated for use on people who have had a sudden loss of heart function (sudden cardiac arrest or SCA).

How does it work? The HeartStart FR3 uses two (2) multifunction defibrillation electrodes (sensors), placed on the patient’s chest, to get a patient’s electrical activity of the heart (electrocardiogram or ECG). If this device detects an abnormal heartbeat, it may advise the user that a "shock" from the defibrillator is appropriate to restore the heart’s normal pumping. If an electric shock is required, the device will deliver a controlled shock to the patient through the multifunction defibrillator electrodes to restore the patient’s heart to a normal rhythm. The user interface will provide voice and text/icon prompts to guide the user through the rescue process, including shock delivery and/or cardiopulmonary resuscitation (CPR).

When is it used? The HeartStart FR3 models 861388 and 861389 are indicated for use by trained responders to treat abnormal heart rhythm (ventricular fibrillation or VF), the most common cause of sudden loss of heart function (sudden cardiac arrest or SCA), and pulseless rapid heartbeat (ventricular tachycardias or VTs) on adults and children over 55 pounds (25 kg) or greater than 8 years old. The models 861388 and 861389 are also indicated for children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key.

What will it accomplish? The combination of CPR and early defibrillation is highly effective in saving patients lives when used 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 FR3 device can reduce the time in cardiac arrest and increase the chance of patient survival.

When should it not be used? The HeartStart FR3 Defibrillator should not be used when a patient is conscious, breathing normally, or has a detectable pulse or other signs of circulation.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data
• Labeling