Alerta De Seguridad para Fabius Anaesthesia Machine

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

¿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
    2018-03-01
  • Fecha de publicación del evento
    2018-03-01
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: dräger fabius anaesthesia machine therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning dräger fabius anaesthesia machine manufactured by drägerwerk ag & co kgaa .The affected products are identified as follows: device: fabius plus xl, fabius tiro, fabius gs premium and fabius plus xl. serial number: askm-0047, askh-0027, askh-0168, askh-0140 and askm-0246. the manufacturer has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator. according to the manufacturer, no serious injury has been reported to date. as a precaution the manufacturer will be updating relevant units. the manufacturer is advising they are currently producing replacement motors for the potentially affected devices. in the interim, the affected users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. for details, please refer to the following tga website: https://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00158-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 mar 2018.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Dräger Fabius Anaesthesia Machine
  • Manufacturer

Manufacturer