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: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
PMA Applicant: AED Battery Exchange, LLC
Address: 1000 Brown Street, Suite 206, Wauconda, Illinois 60084
Approval Date: February 2, 2021
Approval Letter: Approval Order
What is it?
The AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) are non-rechargeable batteries used in certain FDA-approved automated external defibrillators (AEDs).
How does it work?
The AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) are used to provide power to compatible AEDs for the (1) diagnosis of abnormal heart rhythm, (2) defibrillation when a "shock" must be delivered to restore the heart’s normal pumping rhythm, and (3) AED’s self-maintenance.
When is it used?
The AED Battery Exchange provides power to the AEDs they are compatible with, which are as follows:
- The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E.
- The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C.
- The 5070-ABE is indicated for use with the Philips HeartStart OnSite/Home, models M5066A, M5068A, and the FRx, model 861304.
- The FR3-ABE is indicated for use with the Philips HeartStart FR3, models 861388 and 861389.
What will it accomplish?
AEDs are designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. The combination of cardiopulmonary resuscitation (CPR) and early defibrillation is highly effective in saving patient lives when used in the first few minutes of sudden cardiac arrest. For every minute that passes between collapse and defibrillation, survival rates from sudden cardiac arrest decrease by 7-10%.
When should it not be used?
Automated external defibrillators should not be used when a patient is conscious or breathing normally.