Medtronic (NYSE:MDT) issued a voluntary field corrective action today for all of the Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The company said it received reports that the machine may reset spontaneously during normal operation, without an alarm.
After the device resets, it enters standby mode and will not resume ventilation, unless otherwise prompted by a trained healthcare professional.
The reported incidence of this situation is 1 reset in every 7 million hours of ventilation, Medtronic said. Since August 2012, the company has received 12 reports of reset without an alarm of the more than 14,000 ventilators in use. No patient has been injured due to the malfunction, according to Medtronic.
The Fridley, Minn.-based company said it knows the cause of the alarm failure and plans to provide a software service update in May. Healthcare professionals can continue to use the Newport HT70 ventilators, Medtronic said, as long as they ensure that patients connected to the device are constantly monitored by trained caregivers.
The company advised that healthcare professionals project ventilator alarm states outside the patient’s room to alert them of any unexpected reset.
Yesterday, a federal appeals court ruled that the estate of Dr. Michel Mirowski owes Medtronic $6 million to cover legal fees in their long-running patent spat. Mirowski helped invent the implantable defibrillator.