Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Datex - Ohmeda Inc.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 014 10 18 000
  • Date de mise en oeuvre de l'événement
    2018-10-07
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13262
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Safety issue #1: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices utilizing end-tidal control (etc mode) on rare occasions may lose ability to change fresh gas and agent settings when stopping the etc mode. safety issue #2: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices with psvpro spontaneous breathing modes do not provide the psvpro ventilation mode feature of transitioning to simv pcv backup ventilation mode.

Device

Aisys and Aisys CS2 Anesthesia Devices
  • Modèle / numéro de série
    All upgraded Aisys anesthesia devices (i.e. Aisys devices upgraded to software version 11) and Aisys CS2 anesthesia devices (GTIN: 840682102292) with PSVPro option and/or End Tidal Control option. Software versions other than 11.00 and 11 SP01 are not affected.
  • Description du dispositif
    Anesthesia Units
  • Manufacturer
    Datex - Ohmeda Inc

Manufacturer

Datex - Ohmeda Inc