The FDA has issued a recall on the RMU-2000 ARM XR chest compression device created by Defibtech. The purpose of this technology is to maintain oxygenated blood throughout the body. Chest compressions are crucial during cardiac emergencies. A malfunctioning device can significantly endanger a patient’s life.
The notice reports an issue with the motor of the device, which has caused one patient injury and one patient death. As this recall is a Class 1 or the most serious, these devices will be removed and replaced. There are 211 devices affected, with the majority distributed in the US.
What A Class 1 Recall Means
This announcement follows several Class 1 recalls for medical devices in 2024 thus far. Including announcements from companies like Phillips and Abbott. The FDA defines a Class 1 as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” The FDA also has additional regulations for medical device reporting and problems. A Class 1 is the most serious recall and is only used when injury is possible or imminent.
Your Options if Injured by a Defective Medical Device
Despite rigorous testing, some medical devices that should never be used get cleared for use. In other industries, a simple recall or statement by the company is enough to avoid issues. In areas like defective medical devices, the stakes are much, much higher. Many rely on this technology to keep them alive. When a malfunction occurs, it is not just an annoyance, it becomes a matter of life and death.
When someone is injured or dies due to this oversight, you have options for legal remedies. In the State of Ohio, a manufacturer is strictly liable for selling dangerous products. By speaking to a lawyer and filing a claim, you may be able to collect compensation for medical expenses as a result of the defective product, pain and suffering, loss of work, and more.
If you’ve been injured by a defective medical device, especially one that is under recall, it’s essential that you speak to an attorney as soon as possible. Deadlines may apply, so it’s imperative to act quickly.
Choose an Experienced Ohio Defective Product Lawyer
Not all defective product lawyers will be influential in a case like this. To collect compensation for a faulty medical device, you must have experience and knowledge of the FDA’s processes, types of medical devices and their uses, and more. Choosing a lawyer who understands this complex area of law and holds the manufacturer accountable for your injuries is essential.
The recall of Defibtech’s chest compression device underscores the critical need for safety in medical devices. The FDA’s action highlights the potential dangers of malfunctioning equipment and the importance of timely recalls to protect patient safety. Jami Oliver is a leading lawyer for defective medical devices in Columbus and has years of experience fighting for the injured. If you’ve been injured, we invite you to contact us.
