Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
Philips Respironics Inc is updating the use instructions for BiPAP V30, A30, and A40 ventilators due to the risk of 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 13 reported injuries. There have been eight reports of death.
This recall involves correcting devices and does not involve removing them from where they are used or sold.
On March 19, 2024, 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 the urgent medical device recall notice and all relevant appendices to physicians, clinicians, patients, and/or users.
- Complete and return the response form included in the notice.
