Philips Respironics sleep apnea devices are being recalled by Health Canada over malfunction concerns.
The Omnilab Advanced titration system device was designed to regulate the breathing of apnea patients by providing steady airflow through a mask.
Once activated, the device may reboot intermittently for a few seconds, which stops the therapy. However, once rebooted, the machine will continue to function.
In other scenarios, the device may reboot and continue to work but run on factory default settings, rather than the custom settings developed for the patient.
But that’s not always the case, Health Canada says.
After there have been three reboots within 24 hours, the machine will enter what Health Canada says is a “ventilator inoperative state” or will stop working. Devices can enter this state even without a reboot, the recall says.
“Any of the above scenarios could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients,” Health Canada warns.
The recall applies to all lot numbers of model 1044278.
Philips recalled 35 other sleep apnea devices in 2021 saying that foam in the machine, which was designed to reduce sound from the machine, could break up and be ingested by patients.
A class action lawsuit is underway in British Columbia over the recall, with lawyers in the case saying the company knew about the problems for years. However, these claims have not been proven in court.
The lawsuit claims the company waited until it could design a new machine that customers could buy, rather than risk patients buying devices from competitors.
Philips says when it investigated the claims, the company made a voluntary decision to recall the devices.
“Although Philips and Philips Respironics only had a limited amount of information regarding the potential health risks, the recall decision was made in an abundance of caution, after careful consideration of a reasonable worst-case scenario, rather than deferring the recall decision to conduct more definitive testing.”
The company says that 99 percent of the devices have been fixed by replacing the foam with silicone foam.
