Retiro De Equipo (Recall) de Adult Circuit Tubing (Oxygen therapy 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 Fisher & Paykel 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-2012-RN-01156-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-16
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Fisher and paykel healthcare has become aware that one batch of tubes supplied to fisher and paykel healthcare may contain hole damage. if this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
  • Acción
    Fisher and Paykel is recalling affected product and is replacing it with unaffected tubing.

Device

  • Modelo / Serial
    Adult Circuit Tubing (Oxygen therapy delivery system)Product Code: 900MR068Lot Numbers: 110810 & 111020ARTG Number: 129354
  • Manufacturer

Manufacturer