Automatic chest compression device recalled after patient death

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR chest compression device due to significant safety concerns. This is a Class I recall, meaning the FDA believes use of the device “can cause serious injury or death.”

The RMU-2000 ARM XR chest compression device is an automated chest compression device that helps rescuers provide continuous cardiopulmonary resuscitation to patients in cardiac arrest. The recall is due to multiple reports of the device's motor stalling, preventing it from providing compressions as intended. The issue is linked to one injury and one death.

“Use of the affected products can cause serious adverse health consequences, including patient injury, delays in therapy, and death due to a period without compressions to circulate oxygen in the body,” the FDA said in a statement.