Events

Retiro De Equipo (Recall) de Maquet Cardiosave Hybrid and Rescue IABP

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
    19936
  • Fecha de inicio del evento
    2016-03-24
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Causa
    The alarm te63/64 is generated during some circumstances when the flow -i-anaesthesia systems considers that the internal communication does not work as intended. this falsely triggered technical alarm results in that the vaporiser is turned off due to burning issue between the sub systems.
  • Acción
    Software to be upgraded

Device

Maquet Cardiosave Hybrid and Rescue IABP
  • Modelo / Serial
    Model: FLOW-i C20 FLOWE-i C30 and FLOW-i C40, Affected: Part Nos: 66 77 200 ,66 77 300 and 66 77 400
  • Manufacturer
    Maquet Critical Care AB

Manufacturer

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