Shiley TracheoSoft
A tracheotomy is a surgical procedure performed when a patient has a head, neck, or face injury that prevents them from breathing normally through their mouth or nose. Large tumors, inflammation, and cysts around the head or neck can all warrant performing a tracheotomy. Tracheotomies are often performed for comatose patients and surgical cases where a normal endotracheal intubation is too difficult or impossible. The procedure will enable the patient to breathe through a ventilator tube, usually with the assistance of a mechanical ventilator.
Paramedics, physicians, and surgeons are all qualified to perform tracheotomies and trachiostomies. Most emergency medical technicians, however, are not. To perform a tracheotomy, a doctor will make a small incision on a patient's neck, and insert a tube into the trachea. The tube is then secured in place with some form of neck strap. If necessary, the open end of the tube is concatenated to a breathing device.
A tracheotomy is an emergency procedure. It is usually only performed when there is no other alternative for delivering oxygen to the patient. This is because the procedure comes with many risks. These include the possibility of damaging the recurrent laryngeal nerves the nerves that control the vocal chords. Damage to these nerves can cause a patient to have problems with his voice, and may even cause the patient to lose the ability to speak.
A tracheostomy is a version of a tracheotomy that is intended for making more long-term openings. The procedure is very similar to a tracheotomy, and involves placing a tube in a patient's trachea. Since the tube is sometimes meant to be used for longer periods of time, the patient is instructed on home care. Mucous and debris often build up when the tube is in place, so frequent cleaning is necessary. This involves removal of the tube, suctioning the trachea, cleaning the tube, and sometimes replacing the tube completely.
Nellcor, a leading supplier of medical equipment for hospitals and clinics, released a tracheotomy tube that would presumably help physicians perform tracheotomies on patients that are considered more difficult to do the procedure on. The tube was adjustable from both ends. If the patient had a particularly thick neck due to being overweight or if a tumor was present the end near the doctor could be extended to allow the tube into airway as much as necessary. If there was swelling or an obstruction deep in the airway, the end of the tube that was in the patient's neck could be extended past the obstruction.
Unfortunately, the On July 8th, 2004, the Food and Drug Administration officially imposed a Class I recall on all Shiley TracheoSoft XLT Extended Length Tracheostemy Tubes and Disposable Inner Cannulae. Many different sizes and styles of tubes and cannulae are included in the recall. There were several reports of injury and death due to malfunctioning tubes. The tracheotomy tubes were separating from their attachment at the patients' necks, causing them to travel too far into their airways, which in turn interfered with breathing.
Class I recalls are the most serious type of recall that the FDA can impose. Almost three-quarters of a million units had been shipped over four years. A large majority of customers have responded to the recall; however, many injuries were likely to have gone unreported. If you or a loved one may have suffered an injury due to a faulty Shiley TracheoSoft tracheotomy tube, don't hesitate to contact a personal injury attorney. Initial consultations are usually free of charge, and a team of lawyers will help you determine whether or not you are entitled to some form of compensation.
