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 Arjo Huntleigh.

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 082 05 13 000
  • Date de mise en oeuvre de l'événement
    2013-05-21
  • 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=5&rid=3638
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Cause
    The manufacturer conducted field safety correction actions in canada between 2004 and 2007 to provide improved safety instructions and warnings to reduce the risk of the alenti chair tipping and patient falls. the incident rate has since declined. however, the manufacturer continues to receive several incident reports in canada each year. since august 2012, there have been nine tipping and patient slide-out incidents reported in canada. two of these were associated with patient deaths ( more details in attached file ).

Device

Integrated bathing system, Alenti
  • Modèle / numéro de série
    SN : CDB8003-01, CDB8053-01, CDB8103-01, CDB8153-01
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    Part of an integrated bathing system, Alenti™ provides transport and transfer solution for semi-dependent residents.
  • Manufacturer
    Arjo Huntleigh

Manufacturer

Arjo Huntleigh
  • Société-mère du fabricant (2017)
    Getinge AB
  • Représentant du fabricant
    Al-Faisaliah Medical System
  • Source
    SFDA