Events

Alerta De Seguridad O Notificaciones De Seguridad para Powered wheelchairs: Harrier range

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 Invacare.

¿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/2012/060
  • Número del evento
    CON180656
  • Fecha
    2012-08-22
  • Fecha de publicación del evento
    2012-08-22
  • 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/CON180656?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
    The drive wheel may detach from the wheelchair, as a result of being incorrectly refitted due to inadequate service/maintenance instructions in the technical manual.  the manufacturer published a field safety notice (fsn) in april 2012 to notify technicians of the revised removal / refitting procedure. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Acción
    Ensure that technicians responsible for maintenance of Harrier wheelchairs: have a copy of the amended procedure – this is attached to the Field Safety Notice, and can also be downloaded from the Invacare website (external link) are aware of the revised guidance regarding removal and refitting of the drive wheel inform Invacare that the FSN has been received and that the revised procedure has been reviewed and understood.

Device

Powered wheelchairs: Harrier range
  • Modelo / Serial
  • Descripción del producto
    Powered wheelchairs. All chairs in the Harrier range.
  • Manufacturer
    Invacare

Manufacturer

Invacare