Events

Retiro De Equipo (Recall) de Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Siesta Breasy

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Proact Medical Systems (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-00127-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-23
  • 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-00127-1
  • 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
    If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical negative pressure limiter (npl) valve. the npl valve opens if the patient generates a negative pressure of -5 and -7.5 cmh20 (hpa). this opening pressure of the npl valve is defined at an inspiratory flow rate of 3.5-4.5 l/min. if the patient creates a higher flow rate than 4.5 l/min, the npl valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further.
  • Acción
    Device Technologies is providing an updated addendum (Part Number 453564509701 56 052014) to the IFU and recommendation that "If the patient is breathing spontaneously, support ventilation modes (VSV, PSV) could be considered". This action has been closed-out on 08/08/2016.

Device

Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Sie...
  • Modelo / Serial
    Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Siesta BreasyIntelliSave AX700Product Numbers: 866205/10623-00Dameca MRI 508Product Numbers: 866203/10651MRI-00Siesta i WhispaProduct Numbers: 866202/10651-00Siesta iTS Product Numbers: 866163/10653-00Siesta BreasyProduct Numbers: 866204/10652-00All serial numbers affectedARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd