Events

Retiro De Equipo (Recall) de CareFusion - AVEA Ventilator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2015-RN-00433-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-21
  • 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-2015-RN-00433-1
  • 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
    When the avea ventilator develops a malfunction of the pressure transducer in the ventilator that measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated indicating an extended high ppeak or circuit occlusion depending on the specific failure mode within the pressure transducer. most reports of ext high ppeak or circuit occlusion alarms have been detected prior to use of the ventilator on a patient. if a malfunction occurs, a delay of initiation of ventilation may result. under these circumstances, the ventilator by design will alarm and cease ventilation. the safety valve will open allowing patients that can spontaneously breathe to do so. the reported rate of occurrence is very low with no reports of patient injury received to-date.
  • Acción
    Customers are advised that they will be contacted by a Device Technologies representative to arrange for onsite remediation of the affected devices, in the interim if any AVEA ventilator unit exhibits a sustained Ext High Ppeak or Circuit Occlusion alarm followed by the opening of the Safety Valve, that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact Device Technologies Technical Support.

Device

CareFusion - AVEA Ventilator

Manufacturer

Device Technologies Australia Pty Ltd