Events

Retiro De Equipo (Recall) de Infinity Acute Care System Monitoring - M540

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
    22629
  • Fecha de inicio del evento
    2018-02-19
  • 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 has determined that when the infinity m540 patient monitor is placed in standby mode and the user simultaneously connects the infinity mcable- dual hemo or infinity mpod - quad hemo to the infinity m540 patient monitor and then proceeds to zero the invasive pressure channel, in rare cases the invasive pressure visual and audible alarms are not activated.
  • Acción
    Manufacturer to issue advice regarding use

Device

Infinity Acute Care System Monitoring - M540
  • Modelo / Serial
    Model: All released software versions (from VG2.2 to VG6.0), Affected:
  • Manufacturer
    Draegerwerk AG & Co KGaA

Manufacturer

Draegerwerk AG & Co KGaA