Safety Alerts

The Australian Therapeutic Goods Administration has posted a medical device safety alert concerning Respironics Inc OmniLab Advanced + (OLA+) devices [OmniLab Advanced+ International w/ Humidifier (Product number: 1111126) & OmniLab Advanced+ International w/ Heated Tube Humidifier (Product number: 1111127)] [HKMD Number: 150014].

According to the TGA, the OmniLab Advanced + (OLA+) devices feature a Ventilator Inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways:

• The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy with same patient settings or with factory default settings.

OR

• When there are three (3) reboots within a 24-hour period, the device will enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present).

OR

• The device may enter a Ventilator Inoperative state without a reboot preceding this condition

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00259-1

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

Posted on 6 Apr 2024