FDAnews
www.fdanews.com/articles/168718-respironics-recalls-ventilators-due-to-potential-power-failure

Respironics Recalls Ventilators Due to Potential Power Failure

November 24, 2014

Respironics California, a division of Philips Healthcare, is recalling all Esprit V1000 and V200 ventilators with third-generation power supplies and third-generation power supply repair part kits due to problems with AC power.

According to the Class I recall notice, a component in the power supply may prevent the ventilator from using electricity from a socket or switching back to AC power after using battery power. Additionally, if a battery is not present or if it is depleted, the ventilator won’t work. The problems may cause the ventilator to shut off, resulting in injury or death.

Esprit V1000 and V200 ventilators provide constant or periodic breathing assistance to adults and children, including newborns, and are used in hospitals and other healthcare settings.

The recall includes all units distributed between Dec. 21, 2012 and July 9 of this year. No injuries or deaths have been reported, according to the Carlsbad, Calif., company.

Respironics sent an urgent field safety notice on Sept. 17 to all customers who purchased the products, telling them to monitor the power output from the ventilators pending receipt of a replacement unit.

View the recall notice at http://www.fdanews.com/11-24-14-PhilipsRecall.pdf. — Kellen Owings

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