Events

Retiro De Equipo (Recall) de V60 Non Invasive Ventilators (adult mechanical 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 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-2012-RN-00930-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-11
  • 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-2012-RN-00930-1
  • 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
    A review of manufacturing data found that certain blower motor assemblies in the affected v60 ventilators may not meet specifications. specifically, the impeller may not be properly seated on the blower motor shaft. this could subsequently cause the blower to cease functioning which would result in the failure of the v60 ventilator to deliver therapy to the patient due to the loss of ventilation. the v60 ventilator will alert users to malfunctioning blowers through audible and visual alarms.
  • Acción
    Mayo Healthcare is replacing all affected blower motors.

Device

V60 Non Invasive Ventilators (adult mechanical ventilator)
  • Modelo / Serial
    V60 Non Invasive Ventilators (adult mechanical ventilator)Serial Numbers: 100029455, 100030106, 100030107, 100020111, 100030112, 100030113, 100030115, 100030117, 100030118, 100030120 & 100030121ARTG Number: 134845
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd