Events

Retiro De Equipo (Recall) de Neonatal Ventilator

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 Maquet Critical Care AB.

¿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
    22694
  • Fecha de inicio del evento
    2018-03-06
  • 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Causa
    The manufacturer has identified that under certain conditions, an internal communication error might prevent the safety valve to close automatically. as a consequence, ventilation will stop and a high priority alarm, as well as clinical alarms, will be triggered. we are aware of two instances where this issue has caused desaturation but we have no reports of any permanent injuries.
  • Acción
    Software to be upgraded

Device

Neonatal Ventilator

Manufacturer

Maquet Critical Care AB
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA