Thousands of Philips Respironics' ventilators are facing issues with inoperative alarms, posing potential risks to patients, the FDA said June 27.
The agency said there are reports of 65 deaths and 952 injuries related to the issue, but Philips told Becker's the company "does not recognize these numbers."
Philips notified all affected customers of the problem in late March. The company recommends that if the alarm appears, users should disconnect the device and consider alternative ventilation options. Philips also suggests performing a "hard reboot" as a potential solution.
During a reboot, therapy administration may pause for five to 10 seconds before resuming with either default settings or the patient's customized settings, according to Philips' updated instructions for use. However, if the device undergoes three reboots within 24 hours, it could stop therapy and enter an inoperative state.
The ventilators include the BiPAP V30 used in hospitals, BiPAP A30 for home and clinical settings, and BiPAP A40 for "home and clinical settings, including portable applications like wheelchairs and gurneys," according to the FDA. There are about 100,000 affected units, according to Philips.
"At the time of this notification, Philips Respironics had received no reports of serious patient harm for BiPAP V30 devices or for OmniLab Advanced+ devices," the devicemaker said in a June 28 statement. "Regarding BiPAP A30 and BiPAP A40 devices, the company has received 10 reports alleging serious injury, and seven reports of patient death potentially associated with this issue over a 12 year period, between 2011 and 2023."
The devices are not being removed from the market, but the FDA classified the warning as a Class I recall because of the health risks, including hypoventilation, hypoxemia, hypercarbia, respiratory failure and death.
"There have been reports of potential patient harm. Investigation of these reports could not conclusively determine causation," the company said. "Philips Respironics is currently investigating this issue and will implement appropriate actions."
Editor's note: This article was updated July 2 at 8:20 a.m. CT to include additional comment from Philips Respironics.