The United States Food and Drug Administration (FDA) recently issued a recall for the Philips HeartStart MRx defibrillator because it contains a faulty part that can put patients at risk of serious injury and death.
The defective medical device was recalled after it was determined that a glass tube inside the defibrillator has tiny cracks that allow gases to escape and cause the device to malfunction. These cracks also allow electrical surges to cross the defibrillator’s resistors, potentially damaging them and causing the device to fail while it is in automated external defibrillator (AED) mode. When the device fails in this mode, it can still be operated manually. Healthcare providers who have the defibrillator are urged to have the defective glass tube repaired to prevent patient injuries and deaths. In their uncorrected state, these defibrillators can fail at any time.
When a patient is injured by a defective medical device, he or she may seek compensation for his or her damages through a defective medical device claim. When a victim dies from a defective medical device, his or her loved ones may seek compensation for damages through a wrongful death claim.
The FDA’s Recall Classes
The FDA issued a Class 1 recall for the Philips HeartStart MRx defibrillator. This is one of the three classes of recalls it issues.
A Class 1 recall is issued when a defective or dangerous product can potentially cause a victim to suffer severe injury, serious health problems, or death. Examples of Class 1 recalls are foods with unlabeled allergens and defective life-saving medical devices, as seen with the defective defibrillator.
Class 2 recalls are for products that can pose a threat of serious injury, but this threat is fairly minor. Dangerous, defective, and contaminated products that have the potential to cause a temporary health problem are included in this recall class. Class 2 recalls include drugs that are not sufficiently strong to treat patients’ symptoms, but do not pose an actual threat to the patients who take them.
Class 3 recalls are the least severe type of recall, but it is still important for your health and safety for you to comply with these recalls when they are issued. A class 3 recall is issued when a product is labeled incorrectly or suffers from a manufacturing defect, but does not pose a serious health threat to users. Examples of issues that would be classified as Class 3 recalls are packaged foods sold without English labels and minor packaging defects.
Work with an Experienced Chicago Defective Medical Device Lawyer
When you are suffering from an injury because of a defective medical device, you have the right to pursue monetary compensation for your related damages through a personal injury claim. To learn more about this process and what you can expect from your claim, contact our team of defective medical device lawyers at Newland & Newland, LLP today to set up your initial consultation in our office. We serve clients in the Arlington Heights, Palatine, Rolling Meadows, Libertyville, Mundelein, Buffalo Grove, Schaumburg, Elk Grove, and Itasca areas.
(image courtesy of Thomas Kelley)