Events

Alerta De Seguridad para ABP Monitor, Model 90217A

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

¿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
    2011-11-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115a.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
    Mhra fsn safety alert: spacelabs healthcare abp monitor, model 90217a the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on ambulatory blood pressure monitor, model 90217a, manufactured by spacelabs healthcare. the manufacturer has identified a potential error code associated with the use of the product. if external pressure is applied to the cuff during deflation, the monitor will cease to function and display an ec75 error code. according to the manufacturer, there have been no injuries associated with this issue. spacelabs healthcare suggests the users to cycle the power off if error code is observed. the manufacturer is in the progress of upgrading the software. 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

ABP Monitor, Model 90217A
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare