Events

Retiro De Equipo (Recall) de Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific Australia 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-2015-RN-01184-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-03
  • 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-2015-RN-01184-1
  • 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
    Specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. no or poor misting would impact the delivery of aerosolised liquids to the patient, which has the potential to result in harm if used with this defect.
  • Acción
    Thermo Fisher is advising users to inspect and quarantine any affected stock for return to Thermo Fisher. This action has been closed-out on 26/08/2016.

Device

Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + N...
  • Modelo / Serial
    Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)Product Codes: PMD02600, PMD02601, PMD02602, PMD02603, PMD02604, PMD02605, PMD02606Multiple Lot NumbersARTG Number: 214820
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd