Events

Retiro De Equipo (Recall) de ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology

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

¿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-00400-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-07
  • 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-00400-1
  • 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
    A problem was discovered internally with a supplied component for the affected products listed above. when a smart check by roho (smart check), model number smartcheck-01, is used to perform a smart setup with one of the affected cushions, the nonconforming part may adversely affect the setup process resulting in an improper cushion setup. sitting on an over inflated or under inflated sensor ready cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.(please note that this risk is not present when the sensor ready cushion is used without the smart check nor is the risk present when the sensor ready cushion is used with the smart check and the setup is performed using the optional setup mode).
  • Acción
    Permobil is advising users to return affected stock to their distributor. Distributors are requested to then contact Permobil to organise a replacement of the affected stock.

Device

ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology
  • Modelo / Serial
    ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology Multiple Model NumbersSerial Numbers between A2920163 and A3185287Production dates from 8 January 2016 to 28 February 2017ARTG Number: 111106
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia