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 DS USA.

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
    2012-06-19
  • Date de publication de l'événement
    2012-06-19
  • 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_20120619.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: mindray v series patient monitors the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the v series monitor, manufactured by mindray ds usa, incorporation. the manufacturer has identified two software anomalies contained in the v series monitoring system. these anomalies occur only when a vps module is connected to v12 or v21 monitor that has been monitoring a patient of a different size than the one used by the vps module. when a vps module is inserted into a v12 or v21 monitor, the two components can be synchronized so they use either the vps or the monitor settings. the two software anomalies can be summarized as follow:- a software anomaly causing the non invasive blood pressure inflation pressure and arrhythmia algorithm settings to operate based on the settings associated with the patient size previously used on the monitor instead of using the settings associated with the patient size imported from the vps. a software anomaly causing the system to utilize incorrect departmental defaults. the manufacturer advised that vps modules should not be used between systems until the software upgrade has been completed. 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 contact your supplier for necessary actions. posted on 19 june 2012.

Device

V Series Patient Monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Mindray V Series Patient Monitors
  • Manufacturer
    Mindray DS USA

Manufacturer

Mindray DS USA