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

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: 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.

  


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux