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: LIFEPAK® CR2 Defibrillator
PMA Applicant: Physio-Control, Inc.
Address: 11811 Willows Road NE, Redmond, WA 98052
Approval Date: December 21, 2018
Approval Letter: Approval Order
What is it? Physio-Control's LIFEPAK® CR2 Defibrillator (including the QUICK-STEP Pacing/ECG Defibrillation Electrodes, the LIFEPAK CR2 Lithium Battery, and cprCOACH Feedback™ Technology) is a portable, battery operated, public access automatic external defibrillator (AED). The defibrillator is used to treat people experiencing sudden cardiac arrest (SCA) a medical condition in which the heart suddently and unexpectedly stops beating.
How does it work? The LIFEPAK® CR2 Defibrillator uses two (2) multifunction defibrillation electrodes to get a patient's electrical activity of the heart (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 and text/icon instructions to guide the user through the rescue process including cardiopulmonary resuscitation (CPR). If a defibrillation shock is required, the device will either prompt the user to deliver an electrical shock (semi-automatic model) or automatically deliver an electrical shock (automatic model), through the electrodes.
When is it used? The LIFEPAK® CR2 Defibrillator is used when patients 1 year of age and older are showing signs of cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).
The cprCOACH™ Feedback Technology in the LIFEPAK CR2 Defibrillator is used on patients in cardiac arrest and provides CPR guidance in accordance with the American Heart Association (AHA) Guidelines for patients 1 year of age and older.
The LIFEPAK® CR2 Defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.
The LIFEPAK® CR2 AED is to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery.
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. Use of the LIFEPAK® CR2 Defibrillator 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 LIFEPAK® CR2 Defibrillator should not be used when a patient is conscious or responsive.
Additional information (including warnings, precautions, and adverse events):