Philips issues update on ventilator alarm failure

Philips Respironics, Inc. has issued an updated operating manual for the OmniLab Advanced+ (OLA+) ventilator due to a documented failure of the ventilator malfunction alarm that could result in interruption or loss of therapy, consistent with a recall issued by the U.S. Food and Drug Administration (FDA).

The OLA+ ventilator is intended for use by people suffering from obstructive sleep apnea, breathing problems and mixed apnea. It is approved for children aged 7 years and older, as well as for adults.

According to the statement, the recall does not involve removing the devices from places where they are used or sold, but rather updating the instructions for use, and using them without following the updated instructions could result in serious injury or death.

In the event of an alarm failure, the device may fail in one of two ways: by transitioning to a ventilator failure state after three restarts within 24 hours (without therapy and without audible and visual alarms) or by transitioning to a ventilator failure state without prior restart.

The alert issue may be resolved with a software patch available from Philips, or the company will manufacture a replacement device for patients until the affected devices are repaired, according to the statement. The statement updates Philips’ April 1, 2024 urgent recall, which calls for the patient to be immediately disconnected from the OLA+ ventilator and placed on alternate ventilation, if possible, if the ventilator alarm fails.

Device failures can cause interruption or loss of therapy, and their effects include anxiety, confusion, changes in respiratory rate, shortness of breath, tachycardia, respiratory failure, and even death in vulnerable individuals. According to the FDA, one death and 15 injuries have been reported as a result of alarm failure.

In accordance with FDA guidelines, U.S. customers may contact Philips Respironics, Inc. with questions at 1-800-345-6443 or [email protected]. Physicians and patients may report adverse reactions or other device-related issues they have experienced during use to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program.