Events

Alerte De Sécurité sur Graseby MR10 Neonatal Respiration Monitor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Smiths 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
    2011-12-13
  • 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_20111213.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
    Field safety notice: smiths medical graseby mr10 neonatal respiration monitor the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice advising users of a voluntary correction of a limited number of graseby mr10 neonatal respiration monitors. medical device manufacturer, smiths medical, has identified that the three battery straps in the mr10 battery box can become permanently deformed, causing the batteries to make only intermittent contact. if this condition occurs during use, then the mr10 may stop functioning without producing an audible alarm. if this condition occurs during an apnoea event, and if it is not observed that the indicator light is no longer lit, this could result in serious injury or death. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Graseby MR10 Neonatal Respiration Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical Graseby MR10 Neonatal Respiration Monitor
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical