Events

Field Safety Notices about Aquilon series of nebulisers

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by AFP Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    MS35752
  • Date
    2018-05-29
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    Aquilon series of nebulisers - Priority 1 - For Immediate Action
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    HPRA