Events

Alerta De Seguridad para Tri-Flo Subglottic Suction System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Vyaire 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
    2018-08-29
  • Fecha de publicación del evento
    2018-08-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180829a.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: vyaire medical tri-flo subglottic suction system the united states food and drug administration (fda) has issued a medical device safety alert concerning tri-flo subglottic suction system [part number: cm28010; lot/serial numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256], manufactured by vyaire medical. the manufacturer has discovered potential patient safety risk associated with the use of tri-flow subglottic suction system. the distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body. for details, please refer to the following fda website: https://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm?event=80508 if you are in possession of the products, please contact your supplier for necessary actions. posted on 29 august 2018.

Device

Tri-Flo Subglottic Suction System
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Vyaire Medical Tri-Flo Subglottic Suction System
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical