Alerta De Seguridad O Notificaciones De Seguridad para Hill-Rom TotalCare Duo 2

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
    The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed. the mhra has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. no instruction was provided on how to check the condition of the mattress and cover. this presents a risk of cross infection. the manufacturer has omitted to provide customers with information on how to undertake suitable checks and decontamination procedures. the manufacturer does not include full decontamination details with the instructions for use, due to different requirements in different countries. in the uk they are covered in a separate document, w13001uks rev2. two nhs trusts have reported a risk of cross infection with this bed. residues of body fluids from previous occupants have been found under mattress covers. many of these beds are used by intensive care units. the mhra has not received any adverse incident reports of cross infection occurring due to this problem.
  • Acción
    Trace all Hill-Rom TotalCare Duo 2 beds in use and in storage. Contact Hill-Rom on 01530 562167 for copies of the cleaning and disinfection instructions. Unzip the mattress covers and check for signs of fluid contamination on the mattress and damage or holes in the mattress covers. Dispose of damaged covers. If replacement or spare mattresses and mattress covers are required, contact Hill-Rom on 01530 411000 Between each patient use check whether any fluids have penetrated the cover and follow Hill-Rom’s cleaning, disinfection and laundry advice for the covers and mattresses.


  • Modelo / Serial
  • Descripción del producto
    Hospital beds: Hill-Rom TotalCare Duo 2.
  • Manufacturer