Are Your Defibrillators FDA Approved? – FDA Approved AEDs
November 23, 2021
Upgrade Your Defibrillators Before February 3, 2022
The FDA requires AED and defibrillator manufacturers to obtain premarket approval (PMA) for all models that they sell. To obtain a PMA, the manufacturer must prove that its devices are safe, effective and reliable. If a device has not received a PMA, it and its accessories (batteries, electrodes, etc.) will no longer be available from the manufacture after February 3, 2022. If your facility is still utilizing unapproved devices, now is the time to explore alternative options to ensure that the replacement FDA approved defibrillators and AEDs are in place by the deadline.
CLICK BELOW TO START YOUR DEFIBRILLATOR UPGRADE!
Here are some of the most common defibrillators that are frequently upgraded. If you have the Lifepak 20, Zoll M, or Lifepak 12, then it’s time to talk to Soma Tech Intl for your defibrillator upgrade before 2/3/2022!
Why defibrillators need to be FDA Approved?
In 2015 the FDA published an order that requires defibrillator and AED manufacturers to file for premarket approval (PMA) for all defibrillators and AEDs and their accessories. Defibrillators and AEDs need to be FDA approved to ensure that these lifesaving pieces of equipment are safe and reliable. Problems with design and manufacturing issues may have contributed to patient harm.
Which defibrillators and AEDs are currently FDA approved?
There are many defibrillators and AEDs that are currently FDA-approved from top manufacturers like Cardiac Science, Defibtech, HeartSine, Philips, Physio-Control, and Zoll. Soma Tech Intl offers demo and refurbished units that are tested and calibrated back to the original manufacturer specifications by a team of highly skilled and trained biomedical engineers. Below is a table of the units that is separated by both defibrillators and AEDs that Soma Tech offers.
FDA Approved Defibrillators
Defibrillators are used when individuals are experiencing cardiac arrest, cardiac arrhythmia’s, uneven heartbeats, or heartbeats that are too fast or slow. A defibrillator will restore a normal heart beat by sending an eletric shock to the heart. Not only are they capable of sending electric shock, but some of these advanced devices can also monitor vital signs of a patient at the same time. Some of these parameters they can monitor inlcude ECG, NIBP, IBP, CO2, Temperature and respiration.
| Manufacturer | Model | Photos |
|---|---|---|
| Physio-Control | Lifepak 20e |  |
| Physio-Control | Lifepak 15 |  |
| Zoll | R Series |  |
| Zoll | X Series |  |
| Zoll | Propaq MD |  |
FDA Approved AEDs
AED stands for automated external defibrillator. They are an easy-to-use medical device that allows trained and certified individuals to establish an effective heart rhythm. AEDs are used when an individual is experiencing sudden cardiac arrest. When used properly, this device will analyze the heart’s rhythm and deliver a shock if necessary. AEDs are found in most offices and public places and AED certification is open to everyone. If you’re looking for an AED certification class contact your local town’s police or fire department.
| Manufacturer | Model | Photos |
|---|---|---|
| Cardiac Science | PowerHeart AED G3 |  |
| Defibtech | DDU-100 Lifeline |  |
| Defibtech | DDU-2300 Lifeline View |  |
| Philips | HeartStart FR3 |  |
| Philips | HeartStart FRx |  |
| Philips | HeartStart OnSite |  |
| Physio-Control | Lifepak CR Plus |  |
| Physio-Control | Lifepak Expression |  |
| Physio-Control | Lifepak 1000 |  |
| Zoll | AED Pro |  |
| Zoll | AED 3 |  |
Refurbished defibrillators and AEDs from Soma Tech Intl
Soma Tech Intl has one of the largest medical equipment inventories in the country which include refurbished defibrillators and refurbished AEDs. Soma prides themself on only carrying the most trusted and reliable brands and manufacturers in the market like Philips, Zoll, Physio-Control, Cardiac Science, and Defibtech. These AEDs and defibrillators are completely restored and refurbished back to their original manufacturer specifications by highly-trained and certified biomedical engineers at Soma’s ISO:13485 certified facility. All aspects of these units get meticulously inspected and tested. If necessary, parts are replaced and it’s calibrated to make the unit work and function like the day it originally left the manufacturer. Once the unit passes all the quality control tests, it’s gets sent to our cosmetics department. This is where they clean, repaint, and replace decals to not only make the unit function like new but also look like new. Before the defib or AED gets labeled patient ready, it goes through one final quality control test. Then it’s packaged up and ready to be shipped!
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