Events

Alerta De Seguridad para Hudson RCI One-Way Valve with Capped Monitoring Port

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Teleflex 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
    2018-04-13
  • Fecha de publicación del evento
    2018-04-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180413a.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: teleflex medical hudson rci one-way valve with capped monitoring port therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning hudson rci one-way valve with capped monitoring port [product code number: 1644; lot number: 74k1502092 and 74k1601936], manufactured by teleflex medical. it has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. to date, there have been no injuries reported as a result of this issue. according to the manufacturer, disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death. the users are advised to immediately discontinue use and quarantine any products of the affected lot numbers. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00307-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 april 2018.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Teleflex Medical Hudson RCI One-Way Valve with Capped Monitoring Port
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical