Events

Alerte De Sécurité sur Neonatal and Paediatric Endotracheal Tube Clamp/Holder

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par EMS Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-07-25
  • Date de publication de l'événement
    2012-07-25
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120725.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ems medical neonatal and paediatric endotracheal tube clamp/holder the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning all neonatal and paediatric endotracheal tube clamp/holder manufactured by ems medical. according the mhra, 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. based on the information provided by the mhra, ems medical has gone into administration before this issue was identified and it is not known how many affected devices have been supplied. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2012.

Device

Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: EMS Medical Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    DH