The Puritan Bennett ventilator is a critical care ventilator for adults, children and infants. The device landed 501(k) clearance for use with neonatal patients in May 2010.
The ventilator has a software problem that can cause it to shut off, “triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own,” the federal watchdog agency said. The device is marketed for use with critical care patients, so a glitch of this level could be the cause of patient death, according to the FDA’s recall notice.
Covidien said it sent out a letter last month to all customers who bought the device between August 1, 2008, and Oct. 31, 2010. The letter explained the issue and the software update needed to fix the problem, according to the recall notice.
Mansfield, Mass.-based Covidien this week announced an investment in Dublin-based Fire1, a stealthy medtech startup that’s developing “novel therapeutic devices” to “address certain unmet medical needs.”
No further information on its focus or on the details of the funding round were provided, although Covidien vascular therapies president Stacy Enxing Seng will serve on the Fire1 board, suggesting that the startup might play in the vascular space.