Events

Alerta De Seguridad para Trilogy 100 Ventilators

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

¿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
    2012-01-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120113.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
    Fda class i recall: respironics trilogy 100 ventilators the food and drug administration (fda), united states, has issued a class i recall on respironics trilogy 100 ventilators. trilogy 100 ventilators are being recalled due to a manufacturing issue. this issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. in the event of a blower failure, the ventilator will stop delivering therapy and a high priority alarm will sound to alert the caregiver to immediately respond. failure to respond could result in the potential for harm or death of a ventilator-dependent patient. according to the local supplier, the affected product is not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm287528.Htm. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Trilogy 100 Ventilators
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Respironics Trilogy 100 Ventilators
  • Manufacturer
    Respironics

Manufacturer

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