Events

Safety Alert for Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Covidien Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-09-29
  • Event Date Posted
    2014-09-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140929b.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Covidien Ltd Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
  • Manufacturer
    Covidien Ltd

Manufacturer

Covidien Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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