Events

Recall of Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Siesta Breasy

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Proact Medical Systems (Australia) Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00127-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00127-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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