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ZOLL® AED Plus® and Fully Automatic AED Plus® - P160015

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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: ZOLL® AED Plus® and Fully Automatic AED Plus®
PMA Applicant: ZOLL Medical Corporation
Address: ZOLL Medical Corporation, 269 Mill Road, Chelmsford, MA 01824
Approval Date: May 26, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160015a.pdf

What is it? The ZOLL® AED Plus® Automated External Defibrillator (AED) and Fully Automatic AED Plus® are portable, battery operated, public access defibrillators designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating.

How does it work? The ZOLL® AED Plus® and Fully Automatic AED Plus® devices uses two (2) multifunction defibrillation electrodes to get a patient's electrical activity of the heart (electrocardiogram (ECG)). If these devices detects an abnormal heartbeat, it may advise the user that a high-energy shock is necessary. The user interface will provide voice and text/icon prompts to guide the user through the rescue process including cardiopulmonary resuscitation (CPR). These devices will provide an audible rhythmic beeping sound to help the user deliver the correct rate of chest compressions while giving CPR. If a defibrillation shock is required, the Fully Automatic AED Plus® model will deliver an electrical shock automatically, or if the semi-automatic model (AED Plus® ) is used, the device will prompt the user to deliver the electrical shock.

When is it used? The ZOLL® AED Plus® and Fully Automatic AED Plus® devices are used to treat adults or children in cardiac arrest. The patient must be unconscious, not breathing, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). These devices are used on children less than 8 years old or under 55 lbs (25 kg), and patients over 8 years old or over 55 lbs (25 kg).

The devices are intended for use by minimally trained users 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 defibrillation therapy is highly effective in saving patient 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 7-10%. The ZOLL® AED Plus® and Fully Automatic AED Plus® defibrillation waveform shows a greater than 85% success rate – defined as termination of abnormally irregular heartbeat (ventricular fibrillation) or abnormally fast heartbeat (ventricular tachycardia) – when defibrillation was applied within 5 minutes of patient collapse.

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 ZOLL® AED Plus® and Fully Automatic AED Plus® should not be used if the patient is responsive or conscious.

Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness and labeling is available online.

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