Philips Updates Use Instructions for BiPAP A30, A40, and V30

Philips Respironics Inc has issued updated instructions for its V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause interruption or loss of therapy, according to an FDA alert.

According to the FDA, interruption or loss of therapy may lead to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.

Per the FDA alert, there have been 13 reported injuries, and eight reports of death.

Product Use

The FDA provided a description for the affected devices:

• The BiPAP V30 Auto ventilator provides noninvasive 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 noninvasive 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 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.

Reasons for Corrective Action

According to the FDA alert, the devices 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, the FDA says.

Affected Products

More information is available on the FDA website.