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Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032

Automated External Defibrillators - P160032

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: LifeLine/ReviveR DDU-100, LifeLine/ReviveR AUTO DDU-120, LifeLine/ReviveR VIEW DDU-2300, LifeLine/ReviveR VIEW AUTO DDU-2200, LifeLine/ReviveR ECG DDU-2450, and LifeLine/ReviveR ECG + DDU-2475 Automated External Defibrillators
PMA Applicant: Defibtech, LLC
Address: 741 Boston Post Road, Suite 201, Guilford, CT 06437
Approval Date: February 1, 2018
Approval Letter: Not Yet Available

What is it? The LifeLine/ReviveR Public Access Defibrillators (PAD) family of Automated External Defibrillators (AEDs) are portable, battery operated, 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.

How does it work? The Lifeline/ReviveR PAD devices use two multifunction defibrillation electrodes, placed on the patient’s chest, to acquire a patient’s electrocardiogram (ECG). If the device detects an abnormal heartbeat, it may advise the user that a high-energy shock is necessary. The user interface will provide text/icon prompts and 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 Lifeline/ReviveR DDU-100 and 2000 series AEDs are used to treat patients with sudden cardiac arrest or who are unconscious and unresponsive, not breathing (or not breathing normally ), and without circulation (i.e., without a pulse).

What will it accomplish? The combination of CPR and and early 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 7-10%. Use of the LifeLine/ReviveR PAD devices 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 LifeLine/ReviveR PAD 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

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