Events

Recall of Philips Dameca Siesta i TS with an EGM software version lower than 4.0.8 / 7.0.8 (Anaesthesia system)

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-00365-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00365-1
  • 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
    It has been discovered that the touch screen on dameca siesta i ts machine may malfunction, resulting in the screen freezing or in some cases turning black during usage. this results in the user not being able to operate the machine using the touch screen, current information is not displayed and settings cannot be modified. the machine will stop automatic ventilation and an alarm will sound and the user needs to initiate manual ventilation by activating the emergency fresh-gas flow function (emergency o2) on the siesta i ts and maintaining ventilation by means of the ventilation bag (manual ventilation).The highest concern is the potential loss of ventilation and fresh gas flow. if losing ventilation and fresh gas flow, this will result in the need of manual ventilation with external fresh gas flow and emergency equipment.
  • Action
    Users are advised that in cases where automatic ventilation stops, the machine should be restarted (while manually ventilating the patient) and then taken back into normal usage again (return to automatic ventilation and fresh-gas delivery by the electronic gas mixer) after the machine has restarted. Users are also advised to check their existing machine’s version. If EGM software version is lower than 4.0.8/7.0.8 and the problem arises a technician visit will be arranged to upgrade the software. This action has been closed-out on 15/02/2017.

Device

Philips Dameca Siesta i TS with an EGM software version lower than 4.0.8 / 7.0.8 (Anaesthesia sys...

Manufacturer

Proact Medical Systems (Australia) Pty Ltd