Events

Alerta De Seguridad para Engstrom Carestation

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Datex-Ohmeda 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
    2015-02-09
  • Fecha de publicación del evento
    2015-02-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150209.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: datex-ohmeda engstrom carestation health canada posted a medical device safety alert concerning engstrom carestation manufactured by datex-ohmeda inc. the affected model is 1505-9000-000 and the affected lot numbers are cbcp01415, cbcp01452 and cbcp01475. specific combinations of engstrom ventilator casters and bases have been identified that pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing) which can result in serious injury to patients or staff. for details, please refer to the following link: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43635r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 february 2015.

Device

Engstrom Carestation
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Datex-Ohmeda Engstrom Carestation
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc