Events

Avis De Sécurité sur Drager Infinity AC8 Workstation Neonatal Care (Babylog VN500) and Drager Evita V300 with optional PS500 power supply unit

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 Dräger.

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
    Within the framework of our market and product surveillance activities, we have become aware of cases in which the battery runtimes of the optional p8500 power supply unit with the infinity workstation critical care (evita infinity v500) were cut unexpectedly short. the batteries were prematurely depleted despite the device displaying a sufficient charge status. the “battery depleted” alarm was not given in all cases five minutes before the battery was totally depleted, as is specified. once the batteries were totally depleted, the devices each gave the correct alarm to indicate the power failure.

Device

Drager Infinity AC8 Workstation Neonatal Care (Babylog VN500) and Drager Evita V300 with optional...

Manufacturer

Dräger