Philips Respironics Updates Device Use Correction

Philips Respironics has updated use instructions for three bi-level positive airway pressure machines, according to a recall statement posted by the US FDA.

The recall does not include removal of the devices from the market; instead, it provides instructions for correcting the devices in the event of interruptions in or loss of therapy.

The updated use instructions apply to the Philips Respironics’ BiPAP A30, BiPAP A40, and BiPAP V30 Auto, all lots, according to the statement. 

The company is issuing updated instructions because of the risk for potential failure in the ventilator inoperative alarm. This failure can cause interruption or loss of therapy and has been associated with 13 injuries and 8 deaths.

The devices are designed to provide noninvasive breathing support for adults and children who weigh more than 22 pounds with obstructive sleep apnea and respiratory insufficiency. 

According to the statement, any of the affected devices may reboot intermittently, meaning a 5-10 second period of no therapy, with a blank screen and a single audible alert. The devices may then restart with the same patient settings, or they may reboot intermittently and restart with their factory default settings. Additionally, the devices have been reported to enter a “ventilator inoperative” state during which therapy stops and audible and visual alarms are present.

“These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients,” according to the statement.

The BiPAP A30 and BiPAP A40 are suitable for home use and clinical use; the BiPAP V30 Auto is for use in hospitals or institutions.

If the ventilator inoperative alarm occurs, patients who can tolerate interruptions of therapy should be placed on an alternative device; patients who can’t tolerate a therapy interruption should be given alternate ventilation, and clinicians should contact their equipment supplier for an immediate device alternative, according to the recall. A hard reboot may temporarily restore the device, according to the statement.

Healthcare professionals and consumers may report adverse reactions or quality problems associated with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.