FDAJuly 16, 2015device
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
What to do
FDA enforcement status: Terminated
Brands named
covidien lp formerly nellcor puritan bennett inccovidiencovidien lp
Recall history
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