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Objet: Risque de perte de débit de gaz frais - Systèmes d’anesthésie Carestation 620/650/650c A1,
Carestation 620/650/650c A2, Carestation 30 et 9100c NXT
Assurez-vous que tous les utilisateurs potentiels de votre établissement ont pris connaissance de cet avis de sécurité et des actions
recommandées.
Problème Sur les systèmes équipés de l’option Sortie auxiliaire de gaz frais (ACGO), il est possible que le commutateur de la
de sécurité sortie auxiliaire de gaz frais repasse soudainement de la position ACGO à la position circuit fermé. Sur les systèmes
équipés de la fonction Aux O2 + Air, le commutateur risque de repasser soudainement de la position Aux O2 + Air à la
position circuit fermé. Ces situations peuvent conduire à une hypoxie. Il serait toujours possible de ventiler le patient
en utilisant le circuit respiratoire fermé soit en ventilation manuelle soit en ventilation mécanique.
Aucune blessure n’a été signalée pour ce problème.
Instructions Vous pouvez continuer d’utiliser les systèmes d’anesthésie répertoriés dans la liste des produits concernés ci-dessous.
de sécurité Si vous remarquez que le commutateur repasse de la position ACGO/Aux à la position circuit fermé alors que vous
utilisez la fonction ACGO ou Aux O2+Air, servez-vous du circuit respiratoire fermé pour ventiler le patient. Une
indication à l’écran signale si les fonctions ACGO ou Aux O2+Air sont actives. Si le commutateur repasse à la position
circuit fermé, vous remarquez que l’indication à l’écran disparaît, le commutateur tourne sur la position circuit fermé
et le débit du gaz émanant de la sortie ACGO ou Aux O2+Air s’interrompt. Si vous constatez l’un de ces signes, merci
d’utiliser le circuit respiratoire fermé pour ventiler le patient.
À tout moment, le clinicien peut utiliser un ballon auto-gonflant pour ventiler le patient et/ou passer sur un autre
appareil d’anesthésie.
Produits Pour les systèmes d’anesthésie Carestation 620/650/650c A1, Carestation 620/650/650c A2, Carestation 30 et
concernés 9100c NXT, reportez-vous à l’annexe présentant une liste des numéros de série concernés :
Correction GE Healthcare corrigera gratuitement tous les produits concernés. Un représentant GE Healthcare vous contactera afin
du produit de convenir d’un rendez-vous pour cette correction.
Contact Pour toutes questions relatives à cet avis de sécurité ou à l’identification des systèmes concernés, n'hésitez pas à
prendre contact avec votre représentant local de vente ou de service.
FMI_34093_FSN_French_Rev6 1/9
GE Healthcare confirme que les autorités règlementaires concernées ont été informées de cet avis de sécurité.
Soyez assurés que le maintien d’un niveau de sécurité et de qualité élevé est notre principale priorité. Pour toute question, n'hésitez
pas à nous contacter immédiatement.
Cordialement,
FMI_34093_FSN_French_Rev6 2/9
Annexe
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