Events

Retiro De Equipo (Recall) de Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers range: 22611-24876

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge Australia Pty Ltd.

¿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
    RC-2018-RN-00203-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00203-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Getinge have identified that under certain conditions, an internal communication error might prevent the safety valve to close automatically. as a consequence, ventilation will stop and a high priority alarm, as well as clinical alarms, will be triggered. getinge are aware of two instances where this issue has caused desaturation but have no reports of resulting permanent injuries.
  • Acción
    Getinge will initiate an immediate update of all affected Servo ventilator units during which the firmware of an internal circuit board will be upgraded. Users will be contacted by their Getinge sales or service representative to plan for the update of the ventilator.

Device

Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers...
  • Modelo / Serial
    Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455Product: Servo-u Serial Numbers range: 22611-24876ARTG Numbers: 218345, 162468(Getinge Australia - Ventilator, neonatal/paediatric)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA