Events

Retiro De Equipo (Recall) de SERVO-i/s ventilator systems with software version 8.00.00

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2016-RN-00782-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-06-15
  • 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-2016-RN-00782-1
  • 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
    Maquet have become aware of improper behaviour introduced in servo-i and servo-s ventilator system sw version 8.00.00. the improper behaviour in system sw version 8.00.00 appears as follows:· if ventilation is started with infant factory default settings, the following settings will apply: pressure control mode; and 10 cmh2o pc above peep.· the system will deliver a pressure of 20 cmh2o above peep as long as the factory default setting 10 cmh2o is used unchanged.For the infant patient category a delivered pressure of 20cmh2o above peep instead of preset 10cmh2o above peep may cause serious injury. the error was discovered at the production site and there are no reported injuries. the issue would be apparent in the pressure curve and peak pressure displayed on the screen.
  • Acción
    Maquet is advising users to change the default settings of pressure above PEEP in the infant patient category. The ventilator will only deliver a pressure of 20 cmH2O above PEEP if the default start-up configuration of the pressure has not been changed. A new system software version 8.00.01 is available that will eliminate this behaviour. Maquet has initiated an immediate update of all affected SERVO-i and SERVO-s ventilator systems. This action has been closed-out on 27/01/2017.

Device

SERVO-i/s ventilator systems with software version 8.00.00
  • Modelo / Serial
    SERVO-i/s ventilator systems with software version 8.00.00Affected devices: SW Service Release v8.00.00 SERVO-I - 68 85 247 and SW Service Release v8.00.00 ERVO-s – 68 85 259ARTG Number: 162468
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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