Alerte Ou Avis De Sécurité sur Headrest attachment to operating tables

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 Maquet Ltd.

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
  • Numéro de l'événement
    MDA/2011/075
  • Date
    2011-07-06
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • 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
    Concerns about the safe use of a headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0.The manufacturer issued a Field Safety Notice (FSN) for this device on 12 May 2011 (1709Kb) but has not had sufficient confirmation from users that they have received and acted on this information.This alert has been issued in support of the manufacturer’s actions.
  • Cause
    (maquet ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65a0 and 1002.65s0. (mda/2011/075).
  • 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.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Headrests attachment to operating tables with connection fixture 1002.65A0 or 1002.65S0 manufactured by Maquet Ltd.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Colin Moralee Maquet Ltd Tel: 0191 519 6200 Fax: 0191 519 6201Email: cmoralee@maquet.co.uk
  • Société-mère du fabricant (2017)
  • Source
    MHRA