FDA, Philips address potential vent malfunction 

WASHINGTON – The U.S. Food and Drug Administration on June 27 highlighted updated use instructions from Philips Respironics for its BiPAP V30, BiPAP A30 and BiPAP A40 ventilators due to potential interruptions and/or loss of therapy. 

Philips has updated the use instructions for the vents due to a potential failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. 

New 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. 

The potential issue 

The vents may reboot intermittently for five to 10 seconds then restart with the same patient settings; reboot intermittently then restart with factory default settings; and enter a ventilator inoperative state after three reboots within 24 hours, or without a preceding reboot. These issues can result in therapy interruptions or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure or death in vulnerable patients, the FDA says. 

The impact 

There have been 952 reported injuries and 65 reports of death, it says. 

Philips statement 

Philips noted that, while there have been reports of potential patient harm, investigation of these reports could not conclusively determine the cause. The company also noted that customers may continue to use their system in accordance with instructions for use and the field safety notice. 

The company says it is currently investigating the issue and will implement appropriate actions.