Events

Alerta De Seguridad para Maquet FLOW-i Anesthesia System C20, C30, C40

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Maquet Medical Systems 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
    2012-07-09
  • Fecha de publicación del evento
    2012-07-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120709.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: maquet flow-i anesthesia system c20, c30, c40 the united states food and drug administration (fda) has issued a class i recall concerning flow-i anesthesia system c20, c30, c40, manufactured by maquet medical systems usa. this action only affected flow-i anesthesia systems distributed between may 2010 and december 2011. in specific c20, c30 and c40 flow-i anesthesia systems, if the man/auto switch was not fully engaged in either an "on" or "off position, but rather was placed in an "in- between position" for more than five seconds, a technical alarm te 613 may have been generated. activation of the technical alarm te 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. to deactivate the technical alarm te 613, the system must be restarted. the corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm310815.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 july 2012.

Device

Maquet FLOW-i Anesthesia System C20, C30, C40
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Maquet FLOW-i Anesthesia System C20, C30, C40
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA