Events

Retiro De Equipo (Recall) de Iris Hi Lo Bed(adjustable electric bed)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pride Mobility Products Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00842-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00842-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The tga has determined that the side rails supplied with this bed do not comply with the below listed standard and that there is a resulting risk of patient harm, including but not limited to patient entrapment:iec 60601-2-52:2009: medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds while no safety-related incidents have been reported to date, pride australia has, as a precautionary measure have agreed to undertake a recall for product correction.
  • Acción
    Pride, requests that users immediately remove the existing side rails in the event they are installed on the bed. To enable you to remove the existing side rails, Pride have supplied a leaflet of instructions demonstrating how to remove the side rails, along with the Customer Letter as an attachment. Please follow the instructions given to facilitate this recall action.

Device

Iris Hi Lo Bed(adjustable electric bed)

Manufacturer

Pride Mobility Products Australia Pty Ltd