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: Powerheart® AED G3 Pro
PMA Applicant: Cardiac Science Corporation
Address: 500 Burdick Parkway, Deerfield, Wisconsin, 53531
Approval Date: December 6, 2018
Approval Letter: Approval Order
What is it?
Cardiac Science’s Powerheart® AED G3 Pro is a public access automatic external defibrillator AED with related accessories. It is portable, battery operated, self-testing unit used to diagnose and treat life-threatening ventricular arrhythmias in patients who are unresponsive and not breathing normally.
How does it work?
Cardiac Science’s Powerheart® AED G3 Pro uses two (2) multifunction defibrillation electrodes, placed on the patient’s chest (or an optional electrocardiogram (ECG) Patient Monitoring Cable), to acquire a patient’s electrocardiogram (ECG). Both adult and pediatric pads are available. This device uses an ECG analysis algorithm to determine whether a victim has a shockable rhythm and advises a shock when appropriate. The user interface includes ECG display and voice and text to guide the user through the rescue process to include shock delivery and/or cardiopulmonary resuscitation (CPR). The devices incorporate an audible metronome or voice prompt to guide the user as to the correct rate at which chest compressions should be administered. If a defibrillation shock is required, the device will deliver a biphasic, impedance compensating, truncated exponential shock waveform to the patient through the multifunction defibrillator electrodes.
When is it used?
The Powerheart® AED G3 Pro is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:
- not breathing normally, and
- without pulse.
When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Intellisense™ Defibrillation Pad – Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.
The Powerheart® AED G3 Pro is intended to be used by personnel who have been trained in its operation.
What will it accomplish?
The benefit of early defibrillation therapy is survival of patients in cardiac arrest. The time from collapse to defibrillation is critical in patient survival. For every minute that passes between collapse and defibrillation, survival rates from sudden cardiac arrest decrease by 7-10%. Use of the Powerheart® AED G3 Pro can reduce the time in cardiac arrest and increase the chance of survival.
Potential adverse effects for AEDs include inappropriate shock, failure to identify shockable arrhythmias, failure to resuscitate, skin burns around the electrode placement area, interaction with pacemakers, myocardial damage, and bystander shock from patient contact during a treatment event.
When should it not be used?
The Powerheart® AED G3 Pro should not be used when a patient is conscious or breathing normally.