Events

Retiro De Equipo (Recall) de Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por BOC Limited.

¿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-00215-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-13
  • 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-00215-1
  • 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 pressure gauges supplied to boc as part of the inhalo device, may in rare circumstances, have a broken pointer. this failure mode may result in the gauge pointer moving independently of actual cylinder pressure. this will result in inaccurate pressure readings being observed. the situation has been observed where, with a cylinder in a vertical position, the pressure gauge pointer can indicate the cylinder is full, when in fact there is reduced content within the cylinder.
  • Acción
    Customers are advised to confirm that the stock they are using is not faulty and has sufficient contents to administer therapy i.e., all 400CD Inhalo cylinders will need to be checked prior to use as per the Pressure Gauge Check work instruction provided with the customer letter. If no fault is identified, customers can continue to use the product, there is no need to contact BOC. If a faulty pressure gauge is identified, please contact BOC immediately for a free of charge replacement. BOC has implemented additional product testing prior to release from their filling sites, however there is a remote possibility that a pressure gauge pointer may fail during transit/handling.

Device

Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC
  • Modelo / Serial
    Inhalo Medical Oxygen with Integrated Pressure Regulator/FlowmeterBOC Product Code: 400CDARTG Number: 187646
  • Manufacturer
    BOC Limited

Manufacturer

BOC Limited