The FDA has identified Vyaire Medical’s Resuscitation Device & Broselow Convenience Kit as a Class I recall – the most severe type of recall. The use of these devices could cause serious injuries or even death.
Vyaire Medical has issued a recall for their Resuscitation Device & Broselow Convenience Kit because of a design error that creates a great risk to patients. The product can reportedly become stuck to the elbow of the person resuscitating the patient. In these instances, the resuscitation efforts could be stalled, and the patient could be prevented from receiving adequate oxygen. This can cause severe injuries or death. The serious risk presented by this defective product led to the Food and Drug Administration issuing a Class 1 level recall.
Manual Resuscitation Devices
Manual resuscitation devices provide ventilation to patients when those patients cannot breathe on their own. Hospitals use these devices on patients have tracheal tubes or tracheostomy tubes. The AirLife Resuscitation Devices have the potential problem of becoming stuck to the person operating the device. This can prevent the device from providing the oxygen as quickly as it is needed, or inadequate supply. The failure of the device can cause the patient to be deprived of oxygen.
Class 1 Recalls Are Serious
In most cases, recalls are issued by the company that makes a product. If a problem is discovered in a product that causes the product to be in violation of the laws that are overseen by the FDA, companies typically initiate recalls. If the company refuses to take action, the FDA can take legal actions against the company, but the FDA rarely has to take those actions.
The FDA also rates recalls as Class I, II, and III. A level III recall is the least serious and is initiated when the product is unlikely to pose a risk to people’s health. Class II recalls are issued in situations where there is a health risk posed by the product, but where the health complications are reversible, or temporary and where there will not likely be serious or life-threatening consequences.
Class I recalls are only issued by the FDA when the risk to human health is serious, and the product could cause deaths.
The FDA rated the recall of the AirLife device as a Class I recall because the device is designed to provide oxygen to patients who are not able to breathe on their own, a failure of the device to properly provide oxygen to a patient could result in death. The defect creates the potential for the device to become stuck to the operator’s elbow. According to the FDA, this flaw could cause a delay in the ability of medical professionals to get oxygen to the patient.
Medical Device Defects
Patients rely on medical devices to keep them healthy and to save their lives in emergencies. In the event of that, a medical device proves defective; the results can be deadly. Companies that manufacture medical devices are obligated to ensure the safety of these devices and to recall them when a problem is identified.
Manufacturers typically make the decision to recall a device, but in a situation where the company refuses to issue a recall of the device, then the FDA has the power to force a recall. Issuing a recall will not absolve a medical device manufacturer of liability for injuries caused by the product. Issuing a recall will not be viewed as an admission of fault by the company either. However, companies are motivated to issue recalls when they discover defects in their devices because failing to recall a dangerous product puts a company at risk of being found more culpable, and of potentially paying punitive damages to anyone who suffers injuries because of the defects. Defendants are ordered to pay punitive damages when they are viewed as having behaved in a particularly egregious way. These damages are not based on what the plaintiff has lost and are often quite high because they are meant to be felt by the offending party.
Medical product defects are a specific type of product liability claim. Medical products often contain complexities that make defects more challenging to understand.
Product Liability in General
When it comes to product liability, either in the case of medical devices or other products, the defects are the result of faulty design, faulty manufacturing, or a failure to properly warn consumers of the product’s risks.
Products are considered to have a design defect if the product is designed in a way that when it is properly manufactured, and used as intended, it creates an unreasonable risk. Manufacturing defects occur when a properly designed product becomes dangerous because of a problem that occurred in the manufacturing process, for instance, if medication becomes contaminated during production. A warning or marketing error occurs if a product contains inherent risks, but the manufacturer fails to notify consumers of that risk. This would be the case if a medication were known to be dangerous to people with heart conditions, but the labeling of the medicine failed to warn of that risk adequately.
Other Vyaire Recalls
Vyaire has recalled other medical devices in the recent past, including a 2018 recall of the company’s AirLife Humidification Chamber and Heated Breathing Circuit. These devices provide humidified breathing gasses for patients who require ventilation systems. Both adults and children use this product.
According to the FDA, a manufacturing error occurred in the device causing water to pool in the patient circuit. This can lead to patients inhaling fluid, which could lead to severe injuries or death. The FDA declared this recall was as a Class I recall.
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At Parker Waichman LLP, our attorneys have been working on product liability claims, and medical device liability claims for decades. We have recovered a combined total of more than $2 billion in compensation for our clients.
If you or a loved one suffered harm as a result of a defective Vyaire medical device, or any other medical device, contact Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with one of our Resuscitation Device & Broselow Convenience Kit injury attorneys.
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