Events

Alerte De Sécurité sur Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter

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

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
    2014-09-29
  • Date de publication de l'événement
    2014-09-29
  • 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_20140929b.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: covidien ltd aeroneb pro and solo nebuliser systems - friwo power adapter the australia therapeutic goods administration (tga), has issued a medical device safety alert concerning aeroneb pro and solo nebuliser systems - friwo power adapter [product codes: ag-as3000-au and ag-ap1040-au], manufactured by covidien ltd. the manufacturer has been notified by aerogen ltd. that there is a potential hazard with certain friwoac mains power adaptors used with some of their nebuliser systems as supplied with the aerogen pro and aerogen solo nebuliser systems manufactured during the period of week 50/2013 and week 23/2014. the power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user and therefore there is a potential risk of electrical shock. the manufacturer is contacting the hospitals and replacement adapters will be provided. the manufacturer is further requesting the customers to destroy the affected adapters per local disposal processes, when replacement ac mains power adapters are received. for details, please refer to the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01038-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.

Device

Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Covidien Ltd Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
  • Manufacturer
    Covidien Ltd

Manufacturer

Covidien Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH