One of the latest advances in emergency medical care is the availability of external heart defibrillators at gyms, health clubs, schools, arenas and other facilities throughout the Tampa Bay area and the rest of Florida. However, there is some concern about the defibrillators supplied by Cardiac Science Corp. Obviously, a defective defibrillator is of no value and may actually delay or prevent proper medical attention.
The U.S. Food and Drug Administration on Tuesday warned medical device maker Cardiac Science Corp. that it must correct procedures to ensure the quality of its external heart defibrillators. (Reuters)
The company’s automated external defibrillators, or AEDs, are used in schools and other public settings.
The FDA, in a warning letter dated July 11, said an inspection of the company’s Deerfield, Wisconsin, plant, uncovered several violations of safety procedures, including failure to maintain procedures for taking corrective actions when flaws are found.
The FDA said some of the corrective measures the company has taken to address concerns uncovered during the inspection were inadequate. The agency said it would not approve any applications for related lifesaving medical devices until the deficiencies were addressed.