Class 1 Recall: Nellcor Puritan Bennett 980 Ventilator System
The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall for Covidien’s Nellcor Puritan Bennett 980 Ventilator System following reports of a circuit board malfunction which can cause interference with the ventilator’s display screen.
FDA Cites Several Injury Reports
According to MassDevice, the FDA has received several reports of illness and injury in connection with the faulty ventilators since recall efforts first began in October of 2014.
The FDA claims that mistakes made during the manufacturing process may result in part of the ventilator’s circuit board being subject to cracks. The malfunction is most often noted by dimming of the product’s display screen and a burning smell.
Affected ventilators were produced between March 3 and August 19 of 2014.
Class 1 recalls are reserved for instances in which there is a reasonable risk that a defective product could result in serious injury or death.
Similar Covidien Recalls
This most current recall is the latest in a series of recalls involving defective medical devices manufactured by Covidien.
In November, the Nellcor Puritan Bennett 980 ventilator system was recalled for a software glitch that could cause the device to fail after oxygen supplies were disconnected and reconnected.
Another Class 1 recall was issued in January 2014 for a software issue that could cause affected Puritan Bennet 840 units to shut down.