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 CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK Battery Charger
PMA Applicant: Physio-Control, Inc.
Address: Physio-Control, Inc., 11811 Willows Road NE, Redmond, WA 98052 USA
Approval Date: December 21, 2017
Approval Letter: Approval Letter
What is it? The LIFEPAK CR Plus and LIFEPAK EXPRESS 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 LIFEPAK CR Plus and LIFEPAK EXPRESS devices use 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.
The devices also include a battery charger to keep the internal battery at its ideal level.
When is it used? The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are used to treat adults or children in 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 devices may be used with QUIK-PAK defibrillation pads only on adults and children who are 8 years old or more, or who weigh more than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.
The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/Automated External Defibrillator, advanced life support or a physician-authorized emergency medical response training program.
The defibrillators may be used with the CHARGE-PAK battery charger.
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. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillation waveform showed a 98% success rate - defined as termination of abnormally irregular heartbeat (ventricular fibrillation) or abnormally fast heartbeat (ventricular tachycardia) - when defibrillation was applied within about 11 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 LIFEPAK CR Plus and LIFEPAK EXPRESS should not be used when a patient is conscious and responsive.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available on line.