Events

Retiro De Equipo (Recall) de Invacare Platinum Oxygen Concentrator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare 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-2015-RN-00383-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-07
  • 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-2015-RN-00383-1
  • 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
    Invacare has learned that the psi (pressure sensitive interrupter) design for the compressor motor start/run capacitor (dianz brand)could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. these capacitors were utilised in production from march 2010 to august 2012 at one of our manufacturing sites.
  • Acción
    Invacare is providing instruction on how to identify if an affected capacitor is present in the oxygenator. If present end users are requested to contact their distributor to arrange for a technician to replace the capacitor.

Device

Invacare Platinum Oxygen Concentrator
  • Modelo / Serial
    Invacare Platinum Oxygen ConcentratorModel Number : IRC9LXO2AWQ , IRC5LX02AW, IRC5LXAWARTG number: 144033
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd