Events

Alerte De Sécurité sur Platinum Oxygen Concentrator

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Invacare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-05-11
  • Date de publication de l'événement
    2015-05-11
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150511.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: invacare platinum oxygen concentrator australian therapeutic goods administration (tga) posted a medical device safety alert concerning invacare platinum oxygen concentrator, manufactured by invacare. the affected model numbers are irc9lxo2awq , irc5lx02aw, irc5lxaw. the manufacturer has learned that the pressure sensitive interrupter (psi) design for the compressor motor start/run capacitor by one supplier 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. these capacitors were utilised in production from march 2010 to august 2012 at one of their manufacturing sites. 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. the manufacturer 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. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00383-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2015.

Device

Platinum Oxygen Concentrator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Invacare Platinum Oxygen Concentrator
  • Manufacturer
    Invacare

Manufacturer

Invacare