Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed

Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed

A recall has been issued for Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed
. When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.

If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen, can result in possible injury or death.

FDA.gov

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