Events

Retiro De Equipo (Recall) de Corpuls3 CO2 Disposable Naso-oral Adaptor Capone

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2017-RN-00535-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-01
  • 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-2017-RN-00535-1
  • 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
    There have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. the mouth piece is manufactured to be manually removed if clinically necessary. the results of an investigation revealed that it occurred due to a high level of patient agitation. there is a potential risk of asphyxiation if this problem occurs.
  • Acción
    Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated. Users are also requested to retain a copy of their recall letter with the IFU of the affected device.

Device

Corpuls3 CO2 Disposable Naso-oral Adaptor Capone
  • Modelo / Serial
    Corpuls3 CO2 Disposable Naso-oral Adaptor CaponeProduct Code: CP-4234.21All Lot NumbersARTG Number: 281369 and 192745
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd