Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices.
FDA earlier this week said it was designating more Philips recalls as Class I — the most serious kind. The recalls involve all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator (distributed outside the U.S.).
For all three ventilators, an issue has been identified surrounding an internal electrical circuit within the devices. In some cases, the issue impacting the circuit could potentially result in the ventilator ceasing to operate. At least 99,283 devices are affected, with no total device number listed for the V680. The company projects an average of less than one silent shutdown with the affected devices among 1 million uses per year, according to a spokesperson.
Philips is not advising customers to remove the affected ventilators from service as they may continue to be used in accordance with their instructions for use and the guidance in the company’s urgent medical device correction letter. Users are instructed to connect the devices to a nurse call/remote alarm system to provide a backup signal to the clinician even if the primary alarm system does not activate.
The company advised customers that they must implement one or more of the following actions, the spokesperson said:
- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680, and/or
- Connect the V60/V60 Plus or V680 to a nurse call system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse-call/remote-alarm capability, and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.
An alternative means of ventilation should be available whenever the affected ventilators are in use. If a fault is detected, patients should immediately be disconnected and have ventilation started with the alternative option.
“We are committed to providing products and solutions that are safe and reliable for those who depend on them,” Philips Respironics Business Leader David Ferguson said in a statement. “The V60 ventilator has been in service for more than 10 years with a high record of reliability. We take every customer complaint seriously, and whenever we identify an issue, we address it thoroughly and transparently in consultation with the relevant competent authorities. We have created a dedicated team that is focused on addressing the current issue and providing technical assistance where needed.”
While the latest ventilator recalls are unrelated to Philips’ recent woes, they compound the company’s respiratory device problems over the past year and more.
Last year, the company recalled millions of specific ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year.