Events

Retiro De Equipo (Recall) de Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-01038-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01038-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    Covidien is contacting the hospitals and will ship replacement adapters free of charge. Covidien is further requesting the customers to destroy the affected adapters per local disposal processes, when replacement AC mains power adapters are received. This action has been closed-out on 06/07/2016.

Device

Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
  • Modelo / Serial
    Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter Product Codes: AG-AS3000-AU and AG-AP1040-AUARTG number: 140725
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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
    DHTGA