The company’s notice said it received 888 complaints regarding interruptions and/or loss of therapy with several BiPAP devices. The list includes the BiPAP A30, A30 EFL, A30 Hybrid, A40, A40 EFL and A40 Pro devices.
To date, Philips says 10 reports of the issue included an allegation of serious injury. Seven cases reported a patient death.
Philips’ latest ventilator issue adds to the struggles faced by its Respironics unit since a massive recall began in 2021.
The Amsterdam-based medtech giant says its affected products feature a ventilator inoperative alarm. This alarm occurs when the ventilator detects an internal error or a condition that may affect therapy. The device will shut down if the cause of the failure indicates that it can’t deliver therapy.
If this occurs, it could result in an interruption and/or loss of therapy. That may lead to anxiety, confusion/disorientation, increased/decreased respiratory rate, dyspnea, tachycardia, abnormal chest wall movement, mild to severe hypoxemia/lowoxygen saturation, hypercarbia/respiratory acidosis, hypoventilation, respiratory failure or potentially death in the most vulnerable patients.
Facility-based clinicians should immediately remove patients from the device and connect them to an alternate ventilation source if this occurs. Home-based patients should immediately disconnect from the device and connect to an alternative. As an optional step, users can perform a “hard reboot” to temporarily restore device function.
“Philips Respironics is currently investigating this issue and will implement appropriate actions to prevent recurrence,” the notice said. “If you need any further information or support concerning this issue, please contact your local Philips Respironics representative. Philips Respironics regrets any inconveniences caused by this problem. Please be assured that Philips Respironics has patient health and safety at the heart of what we do each and every day. We are committed to improving people’s health around the world.”
Further info from Philips
A Philips spokesperson provided further information via email on the safety notice, saying the company received no reports of patient harm for its BiPAP V30 or OmniLab Advanced Plus units. It received a limited number of “possible rare patient adverse events” for BiPAP A30 and BiPAP A40.
For BiPAP A30 and BiPAP A40, the company received the 10 injury reports and seven death reports. These occurred over a 12-year period between 2011 and 2023. Philips says investigation of the reports “could not conclusively determine causation.”
Customers may continue to use their system in accordance with the device instructions for use and the field safety notice, Philips said.
