Events

Alerta De Seguridad para trilogy ventilators

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

¿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
    2014-02-19
  • Fecha de publicación del evento
    2014-02-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140219.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: philips trilogy ventilators medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning trilogy ventilators with model numbers t100, t200 and t202, shipped between 31 december 2013 and 30 january 2014. the affected ventilators may contain a potentially defective component on the power management board which could affect the function of the trilogy ventilator. in the worst case scenario, failure of this component could result in loss of therapy with reduced alarm functionality. loss of therapy for a patient on ventilator for life support could result in serious injury or death. according to the manufacturer, there have been no reports of death or serious injury related to this potential problem. the manufacturer advises customers to quarantine all affected devices, retrieve affected devices in use and replace them with an unaffected trilogy ventilator. customers are advised to return all affected devices to the manufacturer who will arrange replacement of the products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2014.

Device

trilogy ventilators

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH