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
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
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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