Events

Retiro De Equipo (Recall) de Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AHC Solutions 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-00450-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-29
  • 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-00450-1
  • 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
    The analysis of a customer complaint has identified an issue related to suctioning with the use of the hamilton-g5 and hamil ton-s1 ventilators. after performing the suctioning manoeuvre, including disconnecting the patient, suctioning, and then reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator selected mode maybe applied; this situation can occur independent from the selected patient group (neonate, paediatric, or adult). this situation may occur if the ventilation mode changes during the pre-oxygenation phase. after the suctioning manoeuvre is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. in the worst case, the patient may be either hypo ventilated or hyperventilated.
  • Acción
    AHC is providing instructions to deactivate the suctioning option on all affected ventilators until a software upgrade to version 2.60 has been installed. Users are advised to ensure there are alternative suction devices available.

Device

Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50
  • Modelo / Serial
    Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50Product codes: 159001 & 159005Multiple Serial numbers affected ARTG number: 113999
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd