Retiro De Equipo (Recall) de Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh 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-2016-RN-00560-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-29
  • 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
    The plastic enclosure used in the maxi air supply motor for models 230v is not fire retardant. this can be seen by the "arrows" on the moulded part and was confirmed by an ad-hoc flammability test. this may increase the risk of a fire spreading.
  • Acción
    An ArjoHuntleigh representative will attend the affected hospital to replace the affected blower unit.

Device

  • Modelo / Serial
    Maxi Air Blower Unit - Model 230V (a device designed as a stretcher that is intended for use together with a patient transfer lifting for lifting a patient who is moveable only in a horizontal lying position)Serial Numbers: S0112300, S0112299, S0102544ARTG Number: 215885
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA