Events

Alerta De Seguridad para EnVe and ReVel Ventilators

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

¿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
    2014-10-03
  • Fecha de publicación del evento
    2014-10-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003b.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: carefusion enve and revel ventilators the u.S. food and drug administration (fda) posted a medical device safety alert concerning enve and revel ventilators, manufactured by carefusion. the manufacturer has identified a potential for damage to the power connector on the enve and revel ventilators due to misconnection by the operator. the input port on the ventilators must have the adapters correctly aligned to function properly. incorrect alignment may cause the pins in the connector to bend, causing the ptv ac power adapter and/or ptv auto lighter power cord to be shortened, and preventing charge to the ventilator battery. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69020&w=10012014〈=eng according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 3 october 2014.

Device

EnVe and ReVel Ventilators
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: CareFusion EnVe and ReVel Ventilators
  • Manufacturer
    CareFusion

Manufacturer

CareFusion