Events

Alerte De Sécurité sur V series patient monitors

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

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
    2011-11-22
  • 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_20111122.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
    Mhra field safety notice: mindray v series patient monitor the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that a software anomaly contained in the v series monitor manufactured by mindray. according to the manufacturer, in rare instances, a system database corruption may occur that may cause the v series monitor to reset. the system will return to monitoring after 90 seconds, however, the database corruption may persist. should the database corruption persist, established patient settings may be incorrect and established alarm settings, including those related to arrhythmias, may be incorrect or not available. patient data may not be displayed or only partially displayed. 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 products, please stop using them and contact your supplier for necessary actions.

Device

V series patient monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Mindray V series patient monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray