Events

Alerta De Seguridad para Gemstar docking station (model number: 13075)

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

¿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
    2011-09-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110922.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety alert: gemstar docking station (model number: 13075) it comes to our attention that hospira limited hk alerted the healthcare professionals and customers that complaints related to fluid ingress into the gemstar docking station (model number: 13075) have been received from december 2008 to july 2011. hospira requests healthcare professionals and customers to follow the guidelines below for continued use of their docking station while hospira is in process of developing design improvements to mitigate this risk: do not hang or place fluid containers over the docking station where they could leak fluid on the device; do not spray fluid, such as cleaning solution, directly on the docking station; and clean the docking station using a cloth dampened with an approved cleaning solution according to the local supplier, the product has been distributed to local hospitals and the local supplier has informed the hospitals for observing these guidelines. so far no complaint is received related to this alert. hospira is in the process of developing design improvements to mitigate this risk. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Gemstar docking station (model number: 13075)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gemstar docking station (model number
  • Manufacturer
    Hospira Limited HK

Manufacturer

Hospira Limited HK
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DH