FDA Gives Warning on Healthcare Defibrillators

FDA Gives Warning on Healthcare Defibrillators

December 6th, 2013 // 2:18 pm @

FDA warned this week that thousands of Phillips Healthcare defibrillators may not work right during a medical emergency, due to the failure of electrical parts in the medical devices.

The products are automated external defibrillators, and they are used to restart a patient’s heart. The recall first started in September 2012, and affected 700,000 devices. The program was an electrical failure that could show that the device was ready to use when it was not.

In November, Phillips also told customers that the internal electrical issue may cause the medical devices to not provide the right level of shock. This was a new problem, and the company was only able to inform about 50% of customers about the problem. That is why FDA came out with the warning.

Phillips stated that 88% of customers had gotten warned about the problem, and that it is tracing customers who move or whose addresses are invalid. Phillips has not gotten any reports of patients that were harmed due to the electrical problem in eight years.

The FDA recall is related to three types of Philips defibrillators that were made by the firm from 2005 to 12 under the name HeartStart. FDA has gotten over 1100 complaints about the defective medical devices. There also have been about 590 adverse event reports.


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