Fabius Anesthesia machines are used during operations for the purpose of providing inhaled anesthesia. The recall was issued because when these devices were produced, the oil that should have been removed was not. This defect could cause issues with the position detector of the ventilation motor and lead to a failure of the ventilation process.
When Was the Recall Issued?
A recall Notification letter went out on March 1, 2018, to inform customers that the machines should continue to be used, but that they should ensure that the manual resuscitator, which is used for emergency ventilation, is ready to be used.
Drager, Inc., the device’s manufacturer, stated that the company was working to produce replacement motors and that they would provide these to customers.
What Does Anesthesia Do?
Anesthetics are used in a medical setting to reduce a patient’s pain or prevent the patient from feeling pain at all. There are three different types of anesthesia. In some instances, the anesthesia used may be local. In these cases, the drug only numbs a small part of a patient’s body, and the patient remains conscious and aware, but cannot feel the pain of a minor procedure. Another type is regional, which can block pain in a large area of the body, like one limb, or the entire lower half of the body. Finally, there is general anesthesia, which is used to make a patient unconscious so that he or she does not experience pain from a procedure and does not remember what happened thereafter.
What is an Anesthesia Machine Used For?
Anesthesia machines are used by anesthesiologists to administer a combination of gases to a patient. The machines have become more complicated over the years and are now used to create precise mixtures of gases that can vary as needed. These machines provide the patient’s source of O2, make accurate mixtures of anesthetic gases, allow for ventilation, and contain safety features that reduce the risk of harm to patients and staff.
The work done by an anesthesia machine is extremely important and has to be carried out precisely and carefully. Anesthesia-related errors account for a large number of surgical mistakes. Mistakes involving anesthesia can be fatal or can cause brain damage. In other situations, a patient may not receive adequate medication and could wake up during a procedure and be able to feel what is happening to them.
These mistakes happen more often than one might imagine. One study conducted at Massachusetts General Hospital, which is a highly respected facility, indicated that a shocking 50% of surgical procedures involved a medication error. The risk of an error occurring increased when the procedure was a long one.
While anesthesia provides doctors with the ability to perform surgeries that would otherwise be horrific or impossible, the medications used can be risky for some patients, and in any event, patients can suffer from serious side effects. While modern machines do a lot of the precision work, anesthesiologists must carefully monitor patients so that they can adjust the medication to address any issues.
Why is the Fabius Anesthesia Machine Dangerous?
While anesthesia machines are used to administer medication, they are also used to provide oxygen to a patient while they are unconscious during a medical procedure. The possibility of the Fabius machines failing to ventilate properly could mean the patient is not getting adequate oxygen. The risk is serious and could result in death.
The severity of the problem created by these defective machines is reflected in the Food and Drug Administration’s (FDA) decision to issue a Class I recall. Class I recalls are issued only in situations when a product creates a serious risk to a person’s health and has the possibility of causing death.
What is a Recall?
A company will issue a recall when a product is dangerous or does not comply with laws that the FDA administers. In the majority of situations, the recall is issued by the company without the FDA having to get involved. If a company creates a dangerous product and refuses to recall that project, then the FDA can force the corporation to issue a recall.
If a device presents a risk to human health, the FDA assesses the degree of risk, and then assigns the recall with a “class.” Class III is the least serious health-related recall. These are issued in cases where a product is not likely to negatively impact health. Class II is issued when a product could cause a temporary or reversible medical consequence. Class I are the most serious recalls and are reserved for situations where products create a serious risk to human health, including severe harm or death.
How Recalls Impact Lawsuits
Deciding to issue a recall is a big deal for companies. Recalls cost a lot of money and can cause damage to a brand name. While there are downsides to issuing a recall, a company can be taking a huge risk by failing to recall a dangerous product.
If a company does issue a recall, this does not mean that the company is admitting liability or wrongdoing. If a company refuses to issue a product recall, and the product is found to be dangerous, this can be held against a company, and the company runs the risk of not only paying compensatory damages but of paying costly punitive damages as well.
Of course, customers who ignore recall notices can hurt the chance of their lawsuit being successful. If you own a product that is subject to a recall, it is important to do what the manufacturer has told you to do. Most companies offer refunds, repairs or replacements for defective products.
In the case of medical devices, product liability lawsuits can become highly complex. It is important to speak to an attorney who has plenty of experience handling these types of cases.
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