• 06
  • December
    2010

The U.S. Food and Drug Administration (FDA) has asked makers of various types of heart defibrillators to address a range of design flaws and manufacturing defects that it believes to be responsible for a number of serious injuries and even deaths. Recently, the agency sent letters to a number of manufacturers asking them to meet to discuss known problems and attempt to come up with improvements.

This latest concern by the FDA is in regard to "external defibrillators," which are often found at schools, in gymnasiums, and in airports. According to the FDA, more than 28,000 problems with external defibrillators have been reported in the last five years. In addition, there has been a growing number of recalls announced regarding the product. The FDA issued recalls for 17 of the products in 2009 and issued nine such recalls in 2005.

Generally, these external defibrillators work by placing two paddles on an individual's chest and then delivering an electronic shock meant to restart a heart of fix an abnormal heart rhythm. In the past, known problems with these devices have often been fixed individually without recalling the product or alerting owners of the possible problems.

In one instance, the FDA believes that a circuitry problem with a defibrillator caused the device to shut down instead of delivering a shock to a patent in cardiac arrest. The patient ultimately died, but may not have if the device had functioned properly. It is unclear whether a wrongful death action is underway.

This latest FDA announcement does not seem to affect "internal defibrillators," which are the type implanted under the skin like a pacemaker. If you, or somebody you know, has experienced a cardiac event that resulted in the use of a defibrillator that did not work, you may want to contact someone for legal guidance. If someone was harmed by the defective product, it is important to take action to make sure it does not happen again.

Source: Associated Press, Health officials say design problems with heart defibrillators have caused injury and death, Matthew Perrone 11/15/10