Events

Retiro De Equipo (Recall) de Hamilton Medical G5 / S1 Ventilator with software version V2.42

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

¿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-00285-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-15
  • 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-00285-1
  • 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
    Investigations have shown that after performing the suctioning manoeuvre, including disconnecting the patient, suctioning and reconnecting the patient, the present pattern of ventilation may not continue as expected due to a software issue. under certain conditions, a different ventilation mode than the operator selected mode may be applied. this situation can occur independent from the selected patient group (neonate, paediatric or adult). if the ventilator’s incorrect behaviour is not detected, the patient is ventilated with the ventilation mode active prior to the pre-oxygenation phase. in the worst case, the patient may be either hypo ventilated or hyperventilated.
  • Acción
    The sponsor Taleb is advising customers that a software update (v 2.60) will be installed on all affected units by June/July 2016. As an interim measure, the sponsor will permanently disable the automated suctioning manoeuvre functionality on all affected units. In addition, the operator must verify that the ventilation continues after a suctioning manoeuvre is finished. If the ventilation does not continue as expected, one of the following options can be used to re-establish ventilation as set: • Press the “Manual Breath” key on the ventilator’s front panel. • Select a different ventilation mode. • Switch to the “Standby mode” and return to the previously used ventilation mode. This action has been closed-out on 09/05/2017.

Device

Hamilton Medical G5 / S1 Ventilator with software version V2.42

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia