Alerta De Seguridad O Notificaciones De Seguridad para Invacare Scanbed 750 (SB 750) with integral bed rails

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por manufacturer #17429.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of asphyxiation to children from the potential for entrapment between the wooden bed rails. these beds have been incorrectly supplied in the uk by invacare and its distributors as suitable for children, due to an error in the pre-sales literature. a total of 1077 beds, complete with bed rails, have been sold throughout england and users are unlikely to be aware of the potential for entrapment of children. the manufacturer is unable to trace all these beds. this electric profiling bed is not intended by the manufacturer for occupants under 12 years of age (this may also include small adults of a similar size). this is because of possible head, neck or chest entrapment in the 120 mm space between the integral wooden bed rails. a gap of 120 mm is the maximum stated in standards for bed rails for adults. there are no british standards specifically for beds or bed rails for children. however, the general requirements standard for assistive technology products, bs en 12182, states that the maximum space to avoid entrapment of children’s heads in static equipment is 60 mm. although no injuries have been reported to the mhra, there is the potential for serious or fatal entrapment of a child to occur. the manufacturer has recently updated the pre-sales literature and has issued a field safety notice to clarify this limitation in use. this medical device alert supplements the general information given in db2006(06) ‘safe use of bed rails’, and mda/2007/009 ‘bed rails and grab handles’, both of which can be obtained from our website. to navigate from the mhra home page: www.Mhra.Gov.Uk > publications > safety guidance > device bulletins www.Mhra.Gov.Uk > safety information > safety warnings, alerts and recalls.
  • Acción
    Trace all Invacare Scanbed 750 (SB 750) beds with integral bed rails. Provide child occupants with an alternative bed. Ensure procedures are in place to avoid children using these beds in the future.


  • Modelo / Serial
  • Descripción del producto
    Profiling bed: Invacare Scanbed 750 (SB 750) with integral bed rails.
  • Manufacturer