Events

Retiro De Equipo (Recall) de Draeger Latex Lungs (for V-series 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 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
    16398
  • Fecha de inicio del evento
    2014-03-18
  • 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
    Manufacturer has become aware of an incident where a user suffered an acute allergic reaction after using a drager latex test lung. during investigation of the incident noted that the breathing bag that forms part of the test lung and or other latex natural rubber breathing bags are labelled "nr" (natual rubber). although this is the standard abbreviation for natural rubber this labelling does not comply with the application of international standards for medical devices.Manufacturer points out that the blue reusable breathng bags which bear the marking "nr" do contain natural rubber (latex) drager breathing bags made f latex (blue) are clearly dstngiishablefrom the latex-free version made form silicon (transparent) by their colour.
  • Acción
    Instructions for use to be updated

Device

Draeger Latex Lungs (for V-series ventilators)

Manufacturer

Draegerwerk AG & Co KGaA