Events

Retiro De Equipo (Recall) de Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and 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 Mediquip 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-01485-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-18
  • 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-01485-1
  • 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 manufacturer, o-two medical technologies has been made aware of an incident with one of the equinox o2/n2o mixers where the oxygen supply of the reported mixer was cut off due to a disengaged piston seat in the equalizer that allowed 100% supply of nitrous oxide to be delivered to a patient.
  • Acción
    Mediquip will be contacting customers directly to plan the removal and upgrade of affected units. Loan units will be provided while customer units are being upgraded. In the interim, users are advised to refer to the updated IFU provided with the Customer Letter to use the device with an oxygen analyser.

Device

Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Deliv...
  • Modelo / Serial
    Equinox AdvantageO-Two Medical Technologies - Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery SystemMultiple Serial NumbersARTG 225844
  • Manufacturer
    Mediquip Pty Ltd

Manufacturer

Mediquip Pty Ltd