Dive Brief:
- Defibtech has recalled a chest compression device after receiving reports of one injury and one death, the Food and Drug Administration said Thursday.
- The company asked customers in July to return affected devices due to a problem in the motor that could stop compressions and delay therapy.
- Although one complaint was associated with a death, Defibtech said it had no evidence that the device malfunction was responsible. The recall affects 174 devices in the U.S., as well as 37 products that were sold overseas.
Dive Insight:
Healthcare professionals use Defibtech’s RMU-2000 ARM XR to provide chest compressions on adults whose hearts stop suddenly. The device features a piston that repeatedly presses down on the patient’s chest to mimic manual cardiopulmonary resuscitation. Defibtech markets the device as a way for smaller healthcare teams to provide high-quality resuscitation.
The FDA granted 510(k) clearance to the device in 2021. This is the product’s first recall, according to the FDA’s recall database.
Defibtech began the recall because it was unable to confirm the motor malfunction would not occur in the field. A faulty device is unlikely to cause injury or harm, Defibtech said in its July letter, and the risk of delayed therapy can be mitigated by switching to manual compression. However, the FDA categorized the action as a Class I recall because of the potential for the fault to cause serious injury or death.
The company asked customers to check the serial numbers of their devices against the list of recalled products. Customers should quarantine any affected units, Defibtech said. The company will arrange for the return of the devices and will refund, repair or replace the unit at no cost to customers.