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  1. Device Approvals, Denials and Clearances

HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P PADs and Accessories – P160008

Public Access Automated External Defibrillators and Accessories – P160008

 

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: HeartSine samaritan® PAD 350P (SAM 350P)
HeartSine samaritan® PAD 360P (SAM 360P)
HeartSine samaritan® PAD 450P (SAM 450P)
Pad-Pak-01, Pad-Pak-02, and Pad-Pak-07 accessories
Saver EVO® software version 1.4.0

PMA Applicant: HeartSine Technologies LLC
Address: HeartSine Technologies LLC
121 Friends Lane, Suite 400
Newtown, PA 18940
Approval Date: January 12, 2017
Approval Letter: P160008 Approval Letter

What is it?
The HeartSine samaritan® Public Access Defibrillators (PAD) 350P, 360P, and 450P are portable, battery operated, 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 samaritan® PAD devices use two (2) multifunction Pad-Pak defibrillation electrodes, placed on the patient’s chest, to acquire a patient’s electrocardiogram (ECG). All three (3) models use the same proprietary ECG analysis algorithm to automatically determine whether a victim has a shockable rhythm, and deliver 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 help guide the user to deliver chest compressions at the correct rate.

When is it used?
The samaritan® PAD devices are used to treat cardiac arrest in adults or children. The patient must be unconscious, not breathing, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The devices are used on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak and on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the pediatric Pad-Pak.

The devices are intended for use by minimally trained users in order to initiate the rescue process until emergency medical services (EMS) or other first responders arrive.

What will it accomplish?
The benefit of early defibrillation therapy is increased 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 7% to 10%. Use of the samaritan® PAD device 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, damage to the heart muscle, and bystander shock from patient contact during a treatment event.

When should it not be used?
The samaritan® PAD AED should not be used if the patient is responsive or conscious.

Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data and labeling available online:

Labeling
Labeling Part 2

Other:
Automated External Defibrillator
Ventricular Fibrillation