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 FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
What to Do
- If interruptions of therapy can be tolerated and the ventilator inoperative (vent inop) alarm occurs, the patient/caregiver will have instructions to remove the patient from the device and to place them on an alternative device.
- If interruptions of therapy cannot be tolerated, the patients and caregivers are instructed to provide alternate ventilation AND contact the Equipment Supplier for immediate device alternative.
On March 26, 2024, Philips Respironics, Inc. 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, Inc. 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.
There have been 952 reported injuries. There have been 65 reports of death.
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.
Contact Information
Customers in the U.S. with questions about this recall should contact Philips Respironics, Inc. at 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com.
Additional FDA Resources:
Additional Company Resources:
Company provided information on a recall, is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
