Events

Alerte Ou Avis De Sécurité sur Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Linet.

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
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2011/092
  • Numéro de l'événement
    CON126110
  • Date
    2011-08-18
  • Date de publication de l'événement
    2011-08-18
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON126110?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer issued a field safety notice (fsn) for this device on 15 july 2011, but has not had sufficient confirmation from users that they have received and acted on this information. a copy of the fsn is in the appendix of this alert and it is also available on the mhra website. this alert has been issued in support of the manufacturer’s actions.
  • Action
    Ensure that relevant members of staff are aware of the problem. Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.Action by:All those using, managing and maintaining hospital beds. In particular: nurses, maintenance staff and contractors.

Device

Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds
  • Modèle / numéro de série
  • Description du dispositif
    Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds. Affected serial numbers: Standard: 1739003 – 20053049650 Deluxe: 1752144 – 20053022252
  • Manufacturer
    Linet

Manufacturer

Linet