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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0822-2014

Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.

Publicado el 29 de enero de 2014 · Inicio del retiro: 25 de enero de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Distribuidor
Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
Lote
PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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