Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions

To live, the heart needs to beat at a constant rhythm. When patients’ hearts stop, hopefully someone is there to perform CPR immediately. The body needs the oxygen rich blood from the heart. A person will die without these live saving comprehensions to the heart.

A device that constantly pumps the heart can be crucial for some patients whose heart can not beat on their own. Manual chest compressions can vary in quality depending on the strength, endurance and technique of the person performing them. Automatic devices can provide consistent, high-quality compressions. This ensures the best possible chance of survival.

Debitech’s RMU medical device, when it works properly, can increase the survival rate of patients. Defibtech’s RMU-2000 ARM XR chest compression device is under scrutiny. The US Food and Drug Administration (FDA) issued a Class I recall (the most serious type) for the product. The affected devices are being removed from the market after several reported injuries and a death of a patient.

What is the Problem?

The FDA announced that the chest comprehension device has had problems with the motor that have led to a stop in the automatic compressions. When the product monitor stops compressions, it also stops the oxygen from circulating in the body. This can lead to a delay in therapy, injuries, and death.

Imagine someone goes into cardiac arrest, a child at a sports event, a loved one at home, a patient in a pre-hospital setting. A family, organization, or facility took precautions and purchased a Defibtech RMU-2000 ARM XR Chest Compression Device. A good Samaritan springs into action to perform CPR. They tire waiting for emergency services. They use the expensive devices. Onlookers hope and pray the near lifeless body to resitate. Then suddenly, it stops working. You can almost hear the “flat-line” sound in your head.

The Debitech RMU Recall Affects the Following Device:

RMU-2000 Chest Compression Module
- Product Name: RMU-2000 ARM XR Chest Compression Device
- Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
- Serial Numbers: See full list.

How this Affects Patients and Their Families?

Thousands of families have had loved ones die of heart attacks, cardiac arrest, and other heart issues. Unfortunately, many do not have defibrillators available to keep their hearts beating. In many situations, these failed hearts depend on the people around them and their ability to perform manual compressions correctly and consistently. 70% of heart attack victims die without AED machines. This is because manual compressions can be unreliable.

Patients and their families rely on these automatic devices to live, because they are reliable. Knowing that their loved one is receiving the best possible care, with consistent and accurate compression, can offer reassurance during a highly stressful and emotional time. Families should be able to trust that their loved one is receiving the best treatment.

Defibtech failed in making sure that patients were safe and that their families were at ease. The motor problems provide a lack of trust for both the patients and their families.

Defibtech’s Response

Defibtech issued an Urgent Medical Device Safety Removal letter after reports of the defect. In the letter the company identified 211 devices that should stop being used and be returned to Defibtech immediately.

How KBA Can Help?

At our law firm, we litigate failed medical device cases. If you are a patient that has been injured from or are a family member that has had to see your loved one suffer from Defibtechs chest compression device, Contact Us. We can provide an initial consultation, free of charge, to evaluate the details of your case and help you seek compensation for physical and emotional injuries.