Retiro De Equipo (Recall) de Draeger Evita 300 with optional PS500

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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 cases in which the battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 was rapidly and unexpectedly reduced despite using the most recent power supply firmware (fw1 .50) which was released in november 2015. the batteries prematurely discharged, even though an adequate battery charge status was displayed on the device. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. given these new findings, the decision has been made to cancel the distribution of the updated power supply firmware (fw1.50) and to roll back devices on which this firmware version is already installed to fw1.49.
  • Acción
    Product to be exchanged