FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

New Device Clearance

Philips HeartStart Home OTC Defibrillator - K040904

This is a brief overview of information related to FDA's clearance to market this product. 

Product Name: HeartStart Home Defibrillator (model number M5068A)
Manufacturer: Philips Medical Systems
Address: 2301 5th Avenue, Suite 200, Seattle, WA 98121
Clearance Date: September 16, 2004
Clearance Letter: http://www.fda.gov/cdrh/pdf4/k040904.pdf

What is it? The HeartStart Home Defibrillator is a small, lightweight automatic external defibrillator (AED) specifically designed for home use without a prescription.

HeartStart is a battery-powered device that delivers an external electric shock through the patient’s chest to help restore a normal heart rhythm. It is intended to treat a person who experiences sudden cardiac arrest caused more frequently by ventricular fibrillation. During ventricular fibrillation, the electrical signals in the lower part of the heart are uncoordinated and ineffective. Very little blood is pumped from the heart to the body or the lungs. If ventricular fibrillation is not treated it will result in death.

How does it work?

• In the event of possible cardiac arrest, call 911 or your local emergency phone number first. Then retrieve the HeartStart.
• When the HeartStart is turned on, an automated voice leads the user through step-by-step instructions on how to apply the conductive adhesive pads and use the device.
• HeartStart uses two conductive adhesive pads connected to the device that are attached to the patient’s bare skin.
• HeartStart analyzes the patient’s heart rhythm through the conductive adhesive pads to determine if the patient is in cardiac arrest and needs an electric shock to restore a regular heartbeat.
• HeartStart includes step-by-step coaching for performing CPR on the patient if it is needed.

When is it used? HeartStart is an AED used to treat cardiac arrest. It can be used on an adult or child who:

• is 8 years of age or older,
• weighs at least 55 pounds,
• is in sudden cardiac arrest,
• does not respond when shaken, and
• is not breathing normally.

Special adhesive pads for use on infants and young children are available by prescription.

Who can use it? HeartStart is designed for consumer use in the home. CPR training is recommended for anyone who may use the HeartStart.

What will it accomplish? HeartStart is used to restore a regular heartbeat in a person suffering from cardiac arrest while waiting for emergency responders to arrive.

When should it not be used? HeartStart should not be used on a person who is:

• responsive, or
• breathing.

A defibrillator is not a replacement for seeking medical care. If you have concerns about your health, or an existing medical condition, talk to your doctor before using HeartStart.

Additional information:
FDA Substantial Equivalence letter is available at: http://www.fda.gov/cdrh/pdf4/k040904.pdf

Other:
FDA Talk Paper:
www.fda.gov/bbs/topics/ANSWERS/2004/ANS01314.html

HeartHealth Online:
www.fda.gov/hearthealth

Updated November 8, 2004

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH