The US Food and Drug Administration (FDA) has issued a Class I recall for Defibtech’s RMU-2000 ARM XR chest compression device.
The regulatory agency has tagged the recall as the most serious type and will see the affected devices removed. The recalled devices have been linked to one reported injury and a case of patient death.
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The device malfunction has been linked to “a problem with the device’s motor”, as per the FDA recall notice. The defective motor can cause the automated device to stop chest compressions leading to serious adverse events including patient injuries, delay of therapy and death.
Chest compressions can save a patient’s life in cardiac emergencies, as they help maintain the flow of oxygenated blood through an individual’s body. Automated devices such as Defibtech’s can be helpful as they automate the process of delivering chest compressions and do not fatigue with time.
Defibtech, a Nihon Kohden company, first issued an urgent medical device safety removal letter regarding the defect last month. The company recommended that its customers should identify and quarantine the affected units which can then be returned to the company. The recall affects 211 devices, of which 174 were sent across the US and the rest were exported to Japan.
This year has seen several medical device recalls, with not even the biggest medical device companies being spared. Phillips had to issue multiple recalls for its respiratory devices in the past few months. In May, the FDA issued a Class I recall notice for its Trilogy EVO continuous ventilators. The issue caused a battery life malfunction causing the ventilator to either issue a “loss of power” alarm that stops assisted breathing support therapy while operating on battery power alone or a “battery depleted” alarm while continuing therapy if plugged into a permanent power source.
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By GlobalDataAbbott also had to recall multiple HeartMate systems. In March, the FDA released a Class I correction notice for the company’s HeartMate Touch System after reports of unexpected pump start or stop during certain disconnections between the touch system and controller. In May, Abbott was involved in another Class I recall, for its HeartMate 3 left ventricular assist device. The recall followed 81 incidents, including 70 injuries and two deaths.
