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Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapy

— And some of the remediated breathing devices may not provide any treatment at all, FDA warns

by Elizabeth Short, Staff Writer, MedPage Today

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FDA ALERT Certain Philips Respironics DreamStation breathing devices over a photo of a DreamStation1 device.

Certain , commonly used for treating sleep apnea, may deliver the incorrect prescription or no therapy at all, the FDA warned in a recall announcement.

The recall, designated by the agency as Class I -- the most serious type -- involves over 1,000 DreamStation1 devices that provide both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP). The respirators had been given either incorrect or duplicate serial numbers, leading to communication issues when connecting to the cloud-based care management application and potentially resulting in insufficient or a complete lack of therapy.

There is no device indication for the current user that their DreamStation may not operate properly, which poses serious health risks such as respiratory failure, heart failure, serious injury, and death, according to the FDA.

The DreamStation devices -- used in hospitals, healthcare settings, and in-home by patients -- help keep breathing at a regular rhythm and are often prescribed to obstructive sleep apnea patients to keep airways open while they sleep.

So far, Philips has received 43 complaints regarding this issue, though there have been no reported injuries or deaths.

Philips originally notified users of this recall on February 10, instructing them to locate their CPAP/BiPAP device's serial number, contact providers about manual pressure resets, and to continue to use the current device as is until a replacement device is received or until device changes are made by their provider, "either remotely or in person (fastest)."

Affected product models are the REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM-RECRT. The FDA's covers those distributed from Dec, 1, 2021 to Oct. 31, 2022.

The present recall impacts breathing devices that had been remediated following a massive recall from Philips Respironics in June 2021, related to the devices' polyester-based polyurethane sound abatement foam that turned out to be at risk for degradation and possible inhalation by the user. That recall impacted 5.5 million machines, produced months-long delays in the distribution of new devices, and was followed by recurring issues with the device repair and replacement program.

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    Elizabeth Short is a staff writer for MedPage Today. She often covers pulmonology and allergy & immunology.