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ZOLL® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS® Professional Defibrillators – P160022

Image of the ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® Professional Defibrillators

 

Clockwise from top left: X Series®, R Series®, AED Pro, and AED 3 BLS® Professional Defibrillators


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® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS®
PMA Applicant: ZOLL Medical Corporation
Address: ZOLL Medical Corporation, 269 Mill Road, Chelmsford, MA 01824
Approval Date: May 26, 2017
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160022A.pdf

What is it? The ZOLL® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS® are defibrillators designed to be used by trained medical personnel to treat victims of sudden cardiac arrest (SCA). The X Series® and Propaq® MD also have the following features: electrocardiogram (ECG) monitoring, cardiopulmonary resuscitation (CPR) monitoring, external transcutaneous pacing, non-invasive blood pressure monitoring, blood oxygen saturation (SpO2) monitoring, respiration monitoring, carbon dioxide (CO2) monitoring, invasive pressure monitoring, and 12-lead ECG analysis. The R Series® also has the following features: ECG monitoring, external pacing, SpO2 monitoring, end-tidal (EtCO2) monitoring, and non-invasive blood pressure monitoring. The AED Pro® AED 3 BLS® also have the following feature: ECG monitoring.

How does it work? The ZOLL® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS® devices use two (2) multifunction defibrillation electrodes to acquire a patient’s electrocardiogram (ECG). These devices use an electrocardiogram (ECG) analysis algorithm to determine whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. The user interface includes voice and text/icon prompts to guide the user through the rescue process to include shock delivery and/or cardiopulmonary resuscitation (CPR). The devices incorporate an audible metronome 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 an escalating, impedance-compensating, rectilinear biphasic shock waveform through the multifunction defibrillator electrodes.

When is it used? The ZOLL® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS® devices are indicated for use on victims of sudden cardiac arrest (SCA) who are unconscious, not breathing, and without circulation (i.e., without a pulse). The devices are intended for use by trained medical personnel, (unlike public access defibrillators, which are intended for use by minimally trained lay users). These devices are indicated for use on both adult and pediatric patients.

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 SCA decrease by 7-10%. The ZOLL® X Series®, R Series®, Propaq® MD, AED Pro, and AED 3 BLS® defibrillation waveform shows a greater than 85% success rate – defined as termination of ventricular fibrillation or ventricular tachycardia – when defibrillation is 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.

Potential adverse effects for the 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® X Series®, R Series®, Propaq® MD, AED Pro®, and AED 3 BLS® defibrillation functions should not be used if the patient is responsive or conscious.

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

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