FDA-Device2015-08-26Class I
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).
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
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.
Sold states
Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
Affected count
657 units
Manufactured in
6135 Gunbarrel Ave, Boulder, CO, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2015Don't want to check this manually?
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