On June 27, the FDA announced it updated its recall 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.
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.
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.
