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About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets


What is tracheostomy?

A tracheostomy is an artificial opening in the neck into the windpipe (trachea). This opening is called a stoma. It allows air to go in and out of the lungs. It also allows any mucus to be removed. A small tube (the tracheostomy tube) is inserted through this opening. Breathing occurs through this tube. Thus it creates safe airway access and provide a pathway to remove fluid from the trachea and lungs.

There are different types of tracheostomy tubes that vary in certain features for different purposes. These are manufactured by different companies. Patient is given the tube that best suits his/her needs. The frequency of these tube changes will depend on the type of tube and may possibly alter during the winter or summer months.

However, a specific type of tracheostomy tube will be the same no matter which company manufactures them.

A commonly used tracheostomy tube consists of three parts: outer cannula with flange (neck plate), inner cannula, and an obturator. The outer cannula is the outer tube that holds the tracheostomy open.

Incidents may occur when Tracheostomy Tube Set connector disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube. The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage and death.

The FDA has identified this device as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.



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