Events

Alerta De Seguridad para V Series Patient Monitors

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Mindray DS USA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-06-19
  • Fecha de publicación del evento
    2012-06-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120619.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Mindray V Series Patient Monitors
  • Manufacturer
    Mindray DS USA

Manufacturer

Mindray DS USA