April 27th, 2010
04:17 PM ET

Defibrillator dangers

By Trisha Henry
CNN Medical Producer

The Food and Drug Administration is recalling more defibrillators.

The FDA is recalling Nihon Kohden and GE Responder models of automatic and semiautomatic defibrillators due to faulty components. In November the FDA recalled Powerheart, and CardioVive external defibrillators because the models were found to have defective parts and may not work properly.

The FDA says that about 280,000 defibrillators are used worldwide and that the recalled models may not work during attempts to rescue people in sudden cardiac arrest. SCA is responsible for more than 300,000 deaths each year. SCA causes the heart to stop functioning. In more than 90 percent of cases death occurs. But studies have shown 90 percent of victims can be saved when CPR and a defibrillator are used within the first minute.

The recalled defibrillators, made by Cardiac Science Corporation, may fail to properly deliver a shock and have been found to have faulty parts that may cause them to fail at delivering that lifesaving shock. Other issues with the devices include failures in accurately reading and analyzing the heart rhythm as well as failure to recognize the pad placement during use.

Recalled defibrillators should be repaired or replaced. The FDA says the recalled defibrillators should be used unless another defibrillator is available. It says the potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

For more information and an updated list of the affected models click here.

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soundoff (9 Responses)
  1. James Morgan

    There is nothing in this world that is absolutely reliable.. I've seen people die from crashes where the airbag deployed (Jerk was doing over 100 and crashed into a tree) and other such stupidity. People die in the ambulances rushing to the hospital with regularity, 911 calls get put on hold for minutes.. all have happened and will keep happening.

    An Automatic External Defibrilator SAVES LIVES.. The're not alway perfect. They never work all the time, but they're made to be easy to use and darn near foolproof. When they work as advertised..PEOPLE LIVE.. In a perfect world, all heart attack victims will only happen when the person scheduled to be in an operating room with a world renouned Cardiac Surgeon working on em.. THIS ISN'T A PERFECT WORLD. (and it seems that every lawyer wants to sue anything to get a buck that isn't perfect).

    I feel a darn lot safer knowing my employer put two into the building and taught over fifty people how to use them.. If they need to be repaired.. get them recalled, repaired and back out to work FAST.. the delay will kill people.. and the fear that they "won't work as advertised" may keep people from using them.. Thats a virtual execution of a person by inaction.

    CPR can keep a person from dying, but doing it all alone for the 15-30 minutes an ambulace takes to arrive is almost impossible. An AED will work, and some models will keep monitoring (working) until the battery is exhausted.. far longer than I can do CPR.

    April 28, 2010 at 17:10 | Report abuse | Reply
  2. Robert Meek

    Things like this should NOT be happening with such devices!

    What's the matter with these companies? The people who regulate them?

    April 28, 2010 at 18:03 | Report abuse | Reply
  3. JBecker

    Mr. Meek:: have you been trained in the use of an external defibrillator? Is your CPR certification current? Do you at least know where they are located at your workplace? Would you be able and willing to attempt resuscitation of a co-worker?
    All these questions are more important than "What's the matter with these companies?" They manufacture incredibly complex equipment to be used in a desperate situation; and AS WITH ANYTHING DONE BE MERE HUMAN BEINGS, problems sometimes occur.

    May 1, 2010 at 20:05 | Report abuse | Reply
  4. Cindy

    My father is having significant burning and loss of sensitivity in his fingers, after having an implanted defibulator. His doctor has stated that the 2 are separate issues and is a "coincidence" . Please advise – is this a possible side effect of the defibulator and should we seek medical attention for my father? He has lost feeling in most of his left hand and the burning sensation keeps him from sleeping, most nights.

    December 29, 2010 at 17:45 | Report abuse | Reply
  5. Denise Maier

    I am the Administrator of an American Heart Training Center and a BLS Instructor. I have been selling and training the general public to use AEDs for over 7 years. Over this time, I receive hundreds of stories of lives being saved because there was a defibrillator on site. The Cardiac Science units in the article were not recalled. A field correction was required which could be performed by the owner. If the owner preferred not to perform the update, Cardiac Science sent field representatives to the locations to help. Although the initial notifications and owner requirements seemed frustrating, Cardiac Science continued to provide support to help correct the problem. There were two different issues, as I reported on the website http://www.defibrillator.net, regarding problems with the units. A very small percentage of the hundreds of thousands distributed worldwide actually had to be replaced. Most units were corrected on location with a laptop. I sell AEDs based on the customers needs, and most important, the manufacturers support. Although the initial upgrade started a bit rocky, Cardiac Science provided sufficient support and helped their customers through the process and made the grade. I have worked with recalls and field corrections with Medtronic, Zoll, Philips, and Cardiac Science. They are completed, reported to the manufacturere, and units remain in service to save lives . . . daily. With one student athlete collapsing every three days, and heart disease killing more people that any other disease, we want to help, however possible, to keep these life-saving machines in as many public access locations as possible.

    February 25, 2011 at 08:11 | Report abuse | Reply
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