Events

Retiro De Equipo (Recall) de A3/A5 Anesthesia Delivery System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ulco Engineering 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-2012-RN-01161-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-21
  • 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-2012-RN-01161-1
  • 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 is the possibility of a system leak resulting from improper seating of the co2 absorbent canister gasket. should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked, and locked again to reseat the gasket. if the co2 absorbent gasket is improperly seated, however a potential leak will likely present itself during the automatic circuit leak and compliance test performed at startup and the manual leak test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.This recall action was not notified to the tga before it was initiated by ulco medical.
  • Acción
    Ulco Medical is providing work around instructions and will be replacing the canister gasket to permanently correct the issue.

Device

A3/A5 Anesthesia Delivery System

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA