Events

Retiro De Equipo (Recall) de AirSep Impulse Elite OCD (oxygen conserving device)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Air Liquide Healthcare 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-2013-RN-00462-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-05
  • 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-2013-RN-00462-1
  • 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
    It has been determined that there is a weak spot in the solder joint at the pressure gauge which may cause the development of a gas leak from this area. in extreme cases, there is a small chance that the pressure gauge may suddenly fail resulting in an uncontrolled release of a small volume of high pressure oxygen accompanied by a loud "bang" sound.
  • Acción
    End users are requested to notify Air Liquide Healthcare if they have an affected AirSep Impulse Elite OCD. Air Liquide Healthcare will arrange for the replacement of the unit. Affected units can continue to be used in the interim. To minimise any adverse operation of your Impulse Elite OCD end users are requested to ensure the following steps are taken: - listen for gas leaks emanating from the OCD. Adjust the OCD on the cylinder valve. Should the leak persist, discontinue use and contact AIR LIQUIDE Healthcare customer service. - ensure when replacing the OCD between cylinders to minimise, where possible, standing over or placing you head in close proximity to the pressure gauge. If this is required to read the gauge, then keep the duration of this inspection as short as possible. For further details, http://www.tga.gov.au/safety/alerts-device-airsep-impulse-elite-130723.htm

Device

AirSep Impulse Elite OCD (oxygen conserving device)
  • Modelo / Serial
    AirSep Impulse Elite OCD (oxygen conserving device)Model number: OC006-3Serial number between 088102 and 101360
  • Manufacturer
    Air Liquide Healthcare Pty Ltd

Manufacturer

Air Liquide Healthcare Pty Ltd