Important Safety Alerts

The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning V60 Non-invasive Ventilators which is manufactured by Respironics California Inc., a division of Philips Healthcare.

In the rare even a component fails due to a software issue, the following sequence of events may occur:

• Power Management Board Assembly VMAIN shorts to ground,
• the ventilator shuts down,
• the software repeatedly cycles through part of its initialisation sequence and Power On Self Test, the alarm may not sound to indicate that ventilation therapy has ceased.

The manufacturer advises user that the V60 ventilator may continue to be used in accordance with its directions for use.

The manufacturer will contact 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.

For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00625-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 20 June 2013