Events

Avis De Sécurité sur Aquilon series of nebulisers

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par AFP Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    MS35752
  • Date
    2018-05-29
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aquilon-series-of-nebulisers---priority-1---for-immediate-action&id=71bf0a26-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The hpra has been informed that the aquilon series of nebulisers have been placed on the european market without appropriate ce certification. as such their safety and performance cannot be assured. this safety notice is to alert users and healthcare professionals not to use these devices.
  • Action
    The HPRA advises that users and healthcare professionals: 1. Examine your stock to determine if you have the affected devices. 2. Identify patients who may have the devices. 3. Stop using the device immediately and use an alternative nebuliser. 4. Forward a copy of this safety notice to all relevant personnel within your organisation or to any other organisations/persons to which/whom these devices have been transferred. 5. Report any adverse events/incidents associated with these devices to the manufacturer and the HPRA.

Device

Aquilon series of nebulisers
  • Modèle / numéro de série
  • Description du dispositif
    Aquilon series of nebulisers - Priority 1 - For Immediate Action
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    HPRA