Events

Retiro De Equipo (Recall) de V60 Non-invasive Ventilators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mayo Healthcare 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-2013-RN-00625-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-18
  • 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-2013-RN-00625-1
  • 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
    In the rare even a component fails due to a software issue, the following sequence of events may occur:1) power management board assembly (pmba) vmain shorts to ground,2) the ventilator shuts down,3) the software repeatedly cycles through part of its initialisation sequence and power on self test (post), the alarm may not sound to indicate that ventilation therapy has ceased.
  • Acción
    The V60 ventilator may continue to be used in accordance with its directions for use. A Mayo healthcare representative will be contacting users to schedule the corrective action to upgrade the software. A loan unit will be provided to the users until the corrective action is completed.

Device

V60 Non-invasive Ventilators

Manufacturer

Mayo Healthcare Pty Ltd