Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices
Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.
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Royal Philips will begin this month the unenviable task of repairing and replacing millions of BiPAP, CPAP and other mechanical ventilator devices that were recalled by the manufacturer in June. The effort will take a full year, Philips says.
Calling the situation “untenable” and “unacceptable,” powerful US Sen. Richard Blumenthal has given Vitor Rocha two weeks to answer questions about Philips’ high-risk recall of certain BiPAP, CPAP, and other mechanical ventilator devices.
The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.