FDAFDA · Alimentos y medicamentos·N.º oficial Z-1058-2015
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is 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). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation.
Publicado el 11 de febrero de 2015 · Inicio del retiro: 12 de enero de 2015
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 issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Lote
- All Puritan Bennett 980 ventilators
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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