Alerta De Seguridad para Swift Mobil Shower Chair

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

¿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
    2012-11-22
  • Fecha de publicación del evento
    2012-11-22
  • 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: etac swift mobil shower chair it has come to our attention that medical device manufacturer, etac supply center ab has issued afield safety notice regarding all swift mobil shower chairs with serial number 3829 to 11028. the manufacturer has received information from a few users of malfunctions with the swift mobile shower chair. it was reported that the casters in some cases are loose and in a few cases has fallen off. the manufacturer is unaware that loose casters would have resulted in any harm or serious injuries. there is however a potential risk for harm and injury if the shower chair loses a caster and thus instantly becomes unstable. the manufacturer has after thorough investigation concluded that several root causes has contributed to the reported loosening of casters. the required torque for the caster fastening screws to the frame has in some cases not met the factory specifications. therefore, the manufacturer will replace the casters of the affected shower chairs to ensure a continuous long term safe use. also, the manufacturer advised that there are no reasons for an immediate stop of using the affected product, however as an intermediate precautionary action awaiting the caster replacement, user facilities are requested to be observant and inspect the casters to see if there are visible signs of a caster coming loose. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 november 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Etac Swift Mobil Shower Chair
  • Manufacturer

Manufacturer