Dive Brief:
- Philips sent updated instructions related to a problem with bilevel positive airway pressure, or BiPAP, machines that can cause interruption or loss of therapy.
- Philips recalled three models of BiPAP machines last year due to an alarm that can cause the machines to shut down. The Food and Drug Administration posted a notice on Monday, noting the recall is now associated with 13 reports of injuries and eight deaths. Last year, Philips said it had received reports of 10 serious injuries and seven deaths between 2011 and 2023.
- A Philips spokesperson said in an emailed statement on Monday that the company issued an updated notice in April, which directs patients who cannot tolerate interruptions or loss of therapy to transition to alternative ventilation. The correction is the latest action for Philips’ Respironics business, following several recalls in recent years and a consent decree last year.
Dive Insight:
The recall includes Philips’ A30, A40 and V30 auto BiPAP machines, which are used to treat obstructive sleep apnea and respiratory insufficiency. The V30 is used in hospitals, while the A30 and A40 can be used at home or in a clinical setting. The Philips spokesperson wrote that the update affects nearly 90,000 units worldwide, including nine in the U.S.
A ventilator inoperative alarm with the devices can interrupt treatment, by causing the machines to reboot intermittently and then restart, or enter an inoperative state where therapy is stopped. The problem can potentially lead to patients not receiving enough ventilation, low blood oxygen levels, high levels of carbon dioxide in the blood, respiratory failure or death, according to the FDA notice.
Philips updated the devices’ instructions for use to note that if a patient cannot tolerate interruptions of therapy, users should be provided alternative ventilation and contact the equipment supplier for an immediate device alternative.
Philips has been working through patient settlements and a consent decree with the FDA for its Respironics segments. The company finished paying out about 1 billion euros in settlements in the U.S. in the first quarter, CFO Charlotte Hanneman said in a July earnings call. The settlements were related to a recall that has been ongoing since 2021, when Philips disclosed soundproofing foam used in its respiratory devices could break down and be inhaled by patients.
The consent decree last year barred Philips from selling new continuous positive airway pressure and BiPAP machines and other devices in the U.S. until the company meets certain requirements specified by the FDA. Philips was still working through the consent decree, Hanneman said in a May earnings call, adding that it was too early to determine when that work will finalize.
CEO Roy Jakobs told investors in the July call that Philips is working on efforts related to patient safety and quality. Jakobs said the company has improved its quality management system and processes for corrective and preventive actions, and accelerated its response to newly emerging postmarket signals. As a result, the CEO said, Philips has reduced field actions and product updates by about 20% year-to-date.
