Alerta De Seguridad para GlideScope GVL Video Laryngoscope Reusable Blades

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

¿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
    2012-12-03
  • Fecha de publicación del evento
    2012-12-03
  • 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: verathon glidescope gvl video laryngoscope reusable blades the united states food and drug administration (fda) posted a firm press release concerning glidescope gvl video laryngoscope reusable blades, manufactured by verathon inc. the manufacturer initiated a voluntary recall of glidescope gvl video laryngoscopes reusable blades that were manufactured between december 2010 and august 2011. the recall includes the following models within the specified serial number ranges: glidescope gvl 3, 0574-0007: md10500 to md112387; glidescope gvl 4, 0574-0001: lg105000 to lg112758 and glidescope gvl 5, 0574-0030: xl105000 to xl111798. the firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades. these laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient’s mouths and obstructing the airway or being swallowed. the manufacturer suggests healthcare facilities that have glidescope gvl recalling reusable blades to stop using the blades and contact verathon customer care to obtain a replacement blade. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm330305.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 december 2012.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: Verathon GlideScope GVL Video Laryngoscope Reusable Blades
  • Manufacturer

Manufacturer