Events

Retiro De Equipo (Recall) de ResMed Astral 100 & Astral 150 Portable ventilators

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por ResMed (Australia) 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
    18531
  • Fecha de inicio del evento
    2015-06-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: ResMed (NZ) Ltd, 266 Runciman Road, Pukekohe, Auckland
  • Causa
    Resmed has initiated a recall for product correction following a single incident overseas, in which an astral ventilator had been disconnected from a high-dependency patient without an alarm sounding. it was later found that a health professional had disabled all of the alarms that would normally indicate disconnection.
  • Acción
    Software to be upgraded

Device

ResMed Astral 100 & Astral 150 Portable ventilators
  • Modelo / Serial
    Model: Astral 100 & Astral 150, Affected: All serial numbers
  • Manufacturer
    ResMed (Australia) Ltd

Manufacturer

ResMed (Australia) Ltd