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: X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Battery Pack, SurePower II™ Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3™ Battery Pack, SurePower™ Charger, and SurePower™ Single Bay Charger
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® X Series®, R Series®, AED Pro®, and AED 3 BLS® are defibrillators intended to deliver lifesaving electrical shocks to people experiencing sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating.
The X Series® also has the ability to monitor:
- electrical activity of the heart (electrocardiogram (ECG) monitoring),
- cardiopulmonary resuscitation (CPR),
- temporary cardiac pacing (external transcutaneous pacing),
- blood pressure without puncturing the skin (non-invasive blood pressure monitoring),
- amount of oxygen in the blood (SpO2),
- number of breaths a patient takes per minute (respiration monitoring),
- carbon dioxide (CO2),
- blood pressure (invasive blood pressure monitoring),and
- 12-lead ECG analysis.
The R Series® also has the ability to monitor:
- external pacing,
- inhaled or exhaled CO2 (end-tidal (EtCO2)), and
- non-invasive blood pressure monitoring.
The AED Pro® also has the ability to provide electrical activity of the heartbeat (electrocardiogram (ECG) monitoring),
How does it work? The ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® devices use two multifunction defibrillation electrodes to acquire a patient's electrocardiogram (ECG). If this device detects an abnormal heartbeat, it may advise the user that a high-energy shock is necessary. The user interface will provide voice instructions to guide the user through the rescue process including cardiopulmonary resuscitation (CPR). The device will provide an audible rhythmic beeping sound to help the user deliver the correct rate of compressions while giving CPR. If a defibrillation shock is required, the device will prompt the user to deliver an electrical shock, through the electrodes.
When is it used? The ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® devices are used by trained medical prersonnel to treat both adult and pediatriac patients with sudden cardiac arrest or who are unconscious, not breathing, and without circulation (i.e., without a pulse).
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 sudden cardiac arrest decrease by 7-10%. The ZOLL® X Series®, R Series®, AED Pro, and AED 3 BLS® 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 is applied within 5 minutes of patient collapse.
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®, AED Pro®, and AED 3 BLS® should not be used by minimially trained lay users. The defibrillation functions of these devices should not be used if the patient is responsive or conscious.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.