Automated 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, which means the FDA believes using the device “may cause serious injury or death.”
The RMU-2000 ARM XR Chest Compression Device is an automated chest compression device designed to help emergency responders deliver continuous CPR for patients in cardiac arrest. The recall is in place due to multiple reports of the device’s motor stopping, making it unable to provide compressions as intended. The issue has been linked to one injury and one death.
“The use of affected products may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body,” according to the FDA.
The FDA advisory includes a full list of all relevant unique device identifiers and serial numbers. These automated chest compression devices should be removed from where they are used or sold, the agency emphasized. If any customers have already distributed the devices, all recipients should be told about the issue, either by the distributor or Defibtech.
Defibtech first initiated this recall in July, sending an Urgent Medical Device Safety Removal letter to all customers. The devices were distributed in the United States to customers in Connecticut, Florida, New Jersey, South Carolina and Tennessee. They were also distributed to customers in Japan.
Additional details about are available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.