Events

Alerte Ou Avis De Sécurité sur Neonatal and paediatric endotracheal tube clamp/holder

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 EMS Medical.

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/2012/049
  • Numéro de l'événement
    CON174833
  • Date
    2012-07-23
  • Date de publication de l'événement
    2012-07-23
  • 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/CON174833?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
    Risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder. ems medical has gone into administration and therefore cannot be contacted.   the mhra has issued this medical device alert to ensure that all users are aware of this issue. the composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. ems medical went into administration before this issue was identified and it is not known how many affected devices have been supplied.
  • Action
    Identify, do not use and dispose of affected devices.

Device

Neonatal and paediatric endotracheal tube clamp/holder
  • Modèle / numéro de série
  • Description du dispositif
    Neonatal and paediatric endotracheal tube clamp/holder. All product codes. All lot numbers. This device assists in securing an endotracheal tube (ETT) in position for neonatal and paediatric patients.
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    MHRA