Alerta De Seguridad para SenSit Chair

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

¿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
    2013-07-02
  • Fecha de publicación del evento
    2013-07-02
  • 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: protac sensit chair the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning the following sensit chair manufactured by protac a/s: product no.: 600-601 standard model product no.: 600-701 high model product no.: 600-601-3500 standard model product no.: 600-701-3500 high model protac has heard that an over-excited child in the uk managed to get his head caught in one of the carrying straps on the protac sensit chair. as the strap sat around the child’s throat, he was unable to free himself. however, the staff managed to cut the handle so that fortunately nothing happened to the child. to minimize events of this type from recurring, the manufacturer has implemented the following measures: protac is sending a safety notice together with a warning (please note! take care to ensure the user’s head does not get caught in the carry straps.) to institutions and private customers who have purchased or who are using protac sensit chairs to draw their attention to this potential risk. protac is also sending the safety notice with the warning to all foreign dealers in europe and australia, who must in turn inform their customers, institutions and private customers of this potential risk. protac has redesigned the carrying straps on its protac sensit chair so that the new chair has new and safe straps. protac advises the customers to assess the safety risk and implement any precautionary measures whenever necessary. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con286973 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 july 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Protac SenSit Chair
  • Manufacturer

Manufacturer