Events

Avis De Sécurité sur Carestation 620, 650 in 650c

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 GE Healthcare.

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
    2017-05-16
  • 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
    Problem 1: between the removable receptacle and the lower circuit of the respiratory circuit on the carestation 600 systems, there is possibility of incomplete sealing. this incomplete seal may lead to a re-inhaling of the patient's gases that overturn the carbon dioxide (co2) absorbing agent, which can lead to an unscheduled rise in the level of inhaled co2 (fico2), which can consequently lead to hypercapnia. problem 2: carestation 600 systems can experience an unexpected transition to a failure state. in this case, the following message appears on the screen: "internal system failure prevents normal operation. use a spare respiratory system. turn off and turn on the station to restart. ".

Device

Carestation 620, 650 in 650c
  • Modèle / numéro de série
    Carestation 620 A1 (GTIN: 00840682103985); Carestation 650 A1 (GTIN: 00840682103947); Carestation 650c A1 (GTIN: 00840682103954)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare