Events

Rappel de Invacare Platinum Oxygen Concentrator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Invacare Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00383-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00383-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Invacare Platinum Oxygen ConcentratorModel Number : IRC9LXO2AWQ , IRC5LX02AW, IRC5LXAWARTG number: 144033
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd