Events

Avis De Sécurité sur Oxylog 3000, Oxylog 3000 plus

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 Drägerwerk AG & Co. KGaA.

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
  • 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
    In december 2015, we notified you of an error we noticed in the market for oxylog 3000 family products, where the loss of contact of one of the control buttons triggers an error message (formerly known as a "potentiometer off"). in these cases, acoustic and optical signals are triggered and the respiratory release pressure and ventilation function are interrupted. no injuries were reported in any of these cases. our investigations have shown that fault conditions are triggered by the oxide layer in the potentiometer. oxide layers can form over time when several factors are present, e.G. if you rarely move the buttons or not at all. the proven solution is repeated knob rotation to remove the oxide layer. this recommendation was described in a previous safety notice.

Device

Oxylog 3000, Oxylog 3000 plus

Manufacturer

Drägerwerk AG & Co. KGaA