Philips Respironics updated the use instructions for BiPAP V30, A30, and A40 ventilators due to potential therapy interruptions and serious health risks.

RT’s Three Key Takeaways:

  1. Philips Respironics updated the use instructions for BiPAP V30, A30, and A40 ventilators due to potential therapy interruptions that could lead to serious injury or death.
  2. The recall involves updating device use instructions without removing the devices from service, and the FDA has classified this as the most serious type of recall.
  3. Philips advises patients and caregivers to follow updated instructions immediately, including switching to alternative ventilation if necessary and attempting a hard reboot to restore device function temporarily.

Philips Respironics has updated the use instructions for BiPAP V30, A30, and A40 ventilators due to potential therapy interruptions and/or loss of therapy.

This recall involves updating instructions for using BiPAP V30, BiPAP A30, BiPAP A40 devices, and does not involve removing them from where they are used or sold. The US Food and Drug Administration (FDA) has identified this recall as the most serious type. This device may cause serious injury or death if it continues to be used without following the updated instructions, according to a recall notice from the FDA.  

There have been 911 reports reportedly associated with the recall issue: 894 are malfunctions, 10 injuries, and seven deaths.

Affected Product 

What to Do

On March 26, Philips Respironics sent all affected customers an urgent medical device recall recommending the following actions: 

  • If a ventilator inoperative alarm occurs, immediately remove the patient from the device and connect them to an alternate source of ventilation, if available.
    • As an optional step/action, an attempt to perform a “hard reboot” (forced device restart) that may temporarily restore device function, should be taken. 
  • Identify customer list and where appropriate, distribute this urgent medical device recall notice and all relevant appendices to physicians, clinicians, patients and/or users.
  • Complete and return the response form included in this notice.

Reason for Updates to Use Instructions

Philips Respironics is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. 

The device may:

  • Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with the same patient settings.
  • Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with factory default settings.
  • Enter a ventilator inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours, or without a preceding reboot.

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

Device Use 

The BiPAP V30 Auto ventilator provides non-invasive support for adults and children over 10 kg (22 lbs) with obstructive sleep apnea (OSA) and respiratory insufficiency. It is for use in institutions or hospitals and is not for life support but can be used during intra-facility transport.

The BiPAP A30 ventilator provides non-invasive support for adults and children over 10 kg (22 lbs) with OSA and respiratory insufficiency. It is suitable for home use and clinical settings such as hospitals, sleep labs, and intermediate care institutions.

The BiPAP A40 Pro ventilator provides invasive and non-invasive support for adults and children over 10 kg (22 lbs) with OSA, respiratory insufficiency, or respiratory failure. It is not for life support or transport use but is intended for home and clinical settings, including portable applications like wheelchairs and gurneys.

Customers in the United States with questions about this recall should contact Philips Respironics  at 1-800-345-6443, prompts 4 or 5, or email at [email protected]. 

Photo caption: Philips BiPAP A40

File photo

Editor’s note: This article has been updated to reflect a correction due to an error in reporting from the FDA. The correction states that there have been 911 reports reportedly associated with the recall issue: 894 of which are malfunctions, 10 injuries, and seven deaths. The previous version stated there have been 952 reported injuries and 65 deaths. The FDA says in a statement, “Upon further review, the FDA determined that the original numbers posted in the recall summary were based on an incomplete analysis the agency had performed of the MDRs reportedly associated with these recalls. We regret the error, and it has been corrected.”  

Photo: Philips Ventilator BiPAP A40 EFL. https://www.philips.com/a-w/about/news/media-library/20201104-philips-ventilator-bipap-a40-efl.html