Events

Alerta De Seguridad O Notificaciones De Seguridad para ClinActiv and ClinActiv Plus Therapy Surface

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 Hill-Rom.

¿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
    MDA/2013/086
  • Número del evento
    CON355521
  • Fecha
    2013-12-19
  • Fecha de publicación del evento
    2013-12-19
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON355521?tabName=allTabs
  • 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
    Silicone oil may leak out of the pressure sensor of the mattress and spill onto the floor. patients or carers may slip in the oil and injure themselves. the manufacturer has developed instructions on how to clean up these leaks but they were not included in the field safety notice dated 22 july 2013. in addition, the manufacturer has not received sufficient confirmation from users that they have received and acted upon this information. the mhra remains in discussion with hill-rom about its corrective actions and sensor replacements.
  • Acción
    Ensure all staff are aware of the instructions on how to clean up any silicone oil leakage (see appendix). Ensure the sensors are: checked annually replaced at least every 3 years included in your maintenance programmes. Return the customer response form to Hill Rom.

Device

ClinActiv and ClinActiv Plus Therapy Surface
  • Modelo / Serial
  • Descripción del producto
    Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface. Manufactured by Hill-Rom. Models N02050, N02051, P02062, P02063, P02064 and P02065. All serial numbers are affected
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom