by Elizabeth Short: Complete Post through this link…
ngd-Another Phillips “turd in the swimming pool” that the company just doesn’t seem to be able to remove…
And some of the remediated breathing devices may not provide any treatment at all, FDA warns.
Certain Philips Respironics DreamStation breathing devicesopens in a new tab or window, 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).”
