Events

Rappel de Invacare PerfectO2 Oxygen Concentrator (Provides supplemental oxygen to patients with respiratory disorders)

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-00075-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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-00075-1
  • 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 become aware of five reported instances in the european union in which the capacitor, an internal electrical component of the concentrator, ruptured which results in a potential fire hazard. invacare has learned that the psi (pressure sensitive interrupter) design for the compressor motor start/run capacitor (an internal electrical component of the concentrator) by one supplier could lead to rupture. the 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. there were no injuries reported in any of the five instances.
  • Action
    Invacare is requesting customers to: 1. Examine their stock and quarantine any affected concentrator(s) 2. Inspect each impacted concentrator and if it contains a Dianz capacitor with date codes from 2010.03.XD (March, 2010) to 2012.08.XD (August, 2012) replace the capacitor using the recall replacement kit(s) 1131250 provided to the customer at no charge. 3. Upon completing the correction, quarantine and destroy all impacted capacitors. This action has been closed-out on 26/08/2016.

Device

Invacare PerfectO2 Oxygen Concentrator (Provides supplemental oxygen to patients with respiratory...
  • Modèle / numéro de série
    Invacare PerfectO2 Oxygen Concentrator (Provides supplemental oxygen to patients with respiratory disorders)Model Numbers: IRC5PO2VAW, IRC5PO2AWSerial Numbers Range: 10CSZ43XXXX - 12GSZ62XXXXManufactured between March 2010 to August 2012 Dianz capacitor date codes 2010.03. XD to 2012.08.XD ARTG Number: 144033
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd