Alerta De Seguridad para Anesthesia Workstations and Service Kits

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

¿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
    2013-03-27
  • Fecha de publicación del evento
    2013-03-27
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: spacelabs anesthesia workstations and service kits the u.S. food and drug administration (fda) posted a medical device safety alert concerning bleasesirius anesthesia workstation, bleasefocus anesthesia workstation, and cas i/ii absorber contained in service kits part number 12200902, 050-0659-00, and 050-0901-00, and any workstation installed with the cas i/ii absorber, manufactured by spacelabs medical. these products were manufactured and distributed from 31 oct 2012 to 15 jan 2013. there is a defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. until spacelabs replaces the affected product, the manufacturer advises customers to: immediately cease use of bleasesirius and bleasefocus anesthesia workstations shipped after 31 oct 2012. immediately cease use of service kits part number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a cas i/ii absorber from a service kit. for details, please refer to fda websites http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm345368.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm345346.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 march 2013.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: Spacelabs Anesthesia Workstations and Service Kits
  • Manufacturer

Manufacturer