Events

Alerta De Seguridad para wato ex-55 and wato ex-65

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Shenzhen Mindray Bio-medical Electronics Co Ltd.

¿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
    2012-09-27
  • Fecha de publicación del evento
    2012-09-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120927.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: mindray wato ex-55 and wato ex-65 medical device manufacturer, shenzhen mindray bio-medical electronics co ltd, has issued a field safety notice concerning wato ex-55 and wato ex-65. in april 2012, mindray wato ex-55 and wato ex-65 anesthesia machines have been identified to have pneumatic circuit short connection issue and vaporizer manifold is slipped from pneumatic circuit. according to the manufacturer, the short connection may cause supply failure of the anesthesia agents which patient may become awake during operation. so far, only one clinical case had occurred in the mainland china involving wato ex-65 which the doctor applied proper methods to complete the operation. the root cause of the problem was identified to be due to one employee in the mainland china who did not follow the production process during the assembly. the manufacturer will recall and repair all the affected devices. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 september 2012.

Device

wato ex-55 and wato ex-65

Manufacturer

Shenzhen Mindray Bio-medical Electronics Co Ltd