Events

Alerta De Seguridad para VENTilogic LS ventilators

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

¿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
    2014-01-14
  • Fecha de publicación del evento
    2014-01-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140114.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: weinmann medical technology ventilogic ls ventilators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ventilogic ls ventilators, manufactured by weinmann medical technology. details of the affected products are as follows: item numbers: 27130, 27700, 27710, 27750, 27940, 27950, 27951, 27960, 27970 powerboards: wm39890 index a and index b in extremely rare cases, a diode has failed due to an overload resulting from a voltage surge on the power board. this led to the ventilator failing, meaning that the patient's respiratory support was no longer guaranteed. the manufacturer has modified the layout and components of the affected power board to eliminate the possibility of future occurrence of this fault. devices which are currently in use for life-support ventilation among critical patients have priority and will be corrected by the manufacturer as quickly as possible. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362312 if you are in possession of the product, please contact your supplier for necessary actions. posted on 14 january 2014.

Device

VENTilogic LS ventilators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: WEINMANN Medical Technology VENTIlogic LS ventilators
  • Manufacturer
    WEINMANN Medical Technology

Manufacturer

WEINMANN Medical Technology