Events

Retiro De Equipo (Recall) de Draeger Babytherm Infant Warmers

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 Draegerwerk AG & Co KGaA.

¿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
    17302
  • Fecha de inicio del evento
    2014-09-05
  • 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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Causa
    The manufacturer is aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. the side panel did not open during this incident and no patient was affected., furthermore, if the inner 70mm panels were not always used and if a side panel has not been fully locked into position this may allow the baby's movements to open the side panel - it may be possible for a child to fall out.
  • Acción
    Manufacturer to issue advice regarding use

Device

Draeger Babytherm Infant Warmers

Manufacturer

Draegerwerk AG & Co KGaA