Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
CareFusion, a BD company (NYSE:BDX), provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA® ventilators. The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA), which means the Agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Ventilator shut-off from power failures may lead to serious patient injury or death.
Patients may receive a higher than expected tidal
CareFusion issued the following update regarding its previously announced voluntary recall of AVEA® ventilators. The company initiated the voluntary recall on Sept. 3, 2013.
Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.