Events

Avis De Sécurité sur G5/HAMILTON-S1 ventilators

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Hamilton Medical AG.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-03-07
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Investigations have shown that after performing the suctioning maneuver, including disconnecting the patient, suctioning, and reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator- selected mode may be applied; this situation can occur independent from the selected patient group (neonate, pediatric, or adult). this situation may occur in the hamilton-g5 and hamilton-s1 if the ventilation mode changes during the pre-oxygenation phase. after the suctioning maneuver is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. .

Device

G5/HAMILTON-S1 ventilators
  • Modèle / numéro de série
    All HAMILTON-G5/HAMILTON-S1 ventilators with software versions v2.41, v2.42 and v2.50
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG