Events

Retiro De Equipo (Recall) de Single Limb Circuit for Pneupac Ventilators, with PEEP Valve

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia 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-00047-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-19
  • 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-00047-1
  • 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
    Certain single limb circuits were labelled as “mr conditional” but contained peep valves that should have been labelled as “mr unsafe”.If the affected products are used in an mr environment, there is a potential for the peep valve to become dislodged during the mri procedure. the effect of a reduction of peep pressure could be a reduction in oxygen saturation of the blood which would be detectable by clinical observation of signs and symptoms and through oximetry. also there is the potential for the affected products to create artifacts in the mri scan; however, these artifacts would be highly detectable by the clinician reading the mri.
  • Acción
    Facilities that use the Single Limb Circuit in the MRI suite are requested to quarantine the affected devices. A Smiths Medical representative will arrange for the exchange of unused affected product. This action has been closed-out on 08/08/2016.

Device

Single Limb Circuit for Pneupac Ventilators, with PEEP Valve
  • Modelo / Serial
    Single Limb Circuit for Pneupac Ventilators, with PEEP ValveOrder code:100/905/301 Batch numbers: 121105, 130128, 130225, 130408, 130624, 131209, 140217, 140407, 140428 & 140616 Order code:100/905/302Batch numbers: 120229, 120326, 120402, 120507, 120716, 120820, 130318, 130520, 130819, 131007, 131125, 131216, 140526, 140707 & 140714 ARTG number: 109570
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd