Covidien has voluntarily recalled certain Power Pac batteries for its Newport™ HT70 and HT70 Plus ventilators.
Customers have reported units alarming and switching to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
These conditions have been reported in two types of situations. In the first situation, the screen on the Newport HT70 or HT70 Plus ventilator may indicate that the Power Pac battery is fully charged when it is not. In the second situation, the unit may switch to the backup battery as soon as it is removed from AC power.
In both situations, the ventilator’s alarm sounds and the ventilator will continue to function on the internal backup battery for at least 30 minutes.
However there is a reasonable likelihood of serious adverse health consequences if these issues occur when the user is away from AC power (including during transport) and an alternate source of power cannot be made available before the charge on the internal battery is depleted.
Although no adverse consequences have been reported in connection with these issues, Covidien is warning users to ensure that alternate sources of power, including required power cords, are available nearby until the issue is resolved. The company is also reminding users of common standard clinical practice, which is that alternate means of supporting ventilation should always be available.
Power Pac batteries with Serial Numbers between 2096134110001 and 2292048120050 must be replaced. Affected batteries were distributed within and outside the United States.
Anyone who has Power Pac batteries for Newport HT70 and HT70 Plus ventilators, including distributors, healthcare providers and home users, is instructed to immediately check their Newport HT70 and HT70 Plus ventilators and related Power Pac batteries to determine the serial numbers.
Customers whose Power Pac serial numbers fall within the above range should contact the Newport Medical Technical Support Department to request replacement batteries.
Covidien alerted its customers of the recall by letter on April 4, 2013, and provided instructions for obtaining replacement Power Pac batteries. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have been notified of this recall.
To request the replacement Power Pac batteries, customers are asked to contact the distributor or healthcare provider from whom they obtained the unit. If the affected unit was supplied directly by Newport Medical, customers should contact the Newport Medical Technical Support Department.
For the time being FDA has not classified the recall, but it has posted details of the recall notice here.