Events

Retiro De Equipo (Recall) de Airsep Impulse Elite 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-2017-RN-01448-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-05
  • 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-2017-RN-01448-1
  • 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
    An oxygen conserving device (ocd) is subject to sudden and unpredictable failure when connected to a medical oxygen gas cylinder and pressurised. the cause of failure is due to fatigue and aging of the device as the device is now being operated outside the manufacturer's maximum recommended service life of 7yrs. failure consists of sudden localised pressure loss via the pressure gauge leading to mechanical damage. there is a small chance that this mode of failure could result in the device's outer casing breaking apart to a degree where small plastic projectiles could imact the patient depending on their proximity to the device at the time of failure. this make and model ocd (see above) was discontinued by the manufacturer (airsep) in late 2009 and no new units have been supplied to the market since that time.
  • Acción
    If you own an AirSep Impulse Elite OCD complete and return the supplied Facsimile Reply Form to arrange for the renewal of your OCD. Return the form even if you no longer have an AirSep Impulse Elite OCD or previously had one but are no longer in possession of it. If you have provided any units to other users please pass this letter onto them and inform Air Liquide. If you rent an AirSep Impulse Elite OCD from AIR LIQUIDE Healthcare, we will be contacting you shortly to arrange a suitable time to recover and replace this device with a newer make and model OCD. Affected units may continue to be used until swapped out subject to the precautions described in the letter to customers.

Device

Airsep Impulse Elite Oxygen Conserving Device

Manufacturer

Air Liquide Healthcare Pty Ltd