Federal Court Finalizes Consent Decree Against Philips Respironics
The decree mandates a recall remediation plan and production restrictions to address safety concerns following the widespread 2021 recall of CPAP and BiPAP machines.
Tag: CPAP BiPAP and PAP therapy
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FDA: ‘Carefully Monitor’ Philips CPAP Device for Overheating
The FDA received over 270 reports related to thermal issues such as fire, smoke, burns, and other signs of overheating while patients are using Philips DreamStation 2 CPAP machines.
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CPAP Cuts OSA Patients’ Cardiovascular Death Risk by 36%
A small patient trial also suggests CPAP may be more effective than a weight-loss drug in tackling clogged arteries.
Monaghan Inks Deal to Provide Premier With Respiratory Devices
The new partnership adds Monaghan respiratory therapy products to Premier’s purchasing and supply chain system.
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FDA Expands Clearance of Luna G3 Bilevel for NIV
The Luna G3 Bilevel S/T 30Vt was granted 510(k) clearance by the US FDA for use as a noninvasive ventilator (NIV), according to manufacturer React Health.
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Caire Adds Repair Authority to Service Support Network
In response to increased demands on oxygen equipment fleets, Caire has added Repair Authority to the company’s Authorized Service Center network.
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Philips Mask Recall: Five CPAP/BiPAP Masks Recalled Due to Risk of Injury, Death
Philips Respironics has recalled certain CPAP and BiPAP masks containing magnets that may cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices and metallic objects in the body, according to an FDA alert.
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Additional Recall for Certain Philips BiPAP Devices
Certain Philips BiPAP devices are being recalled due to the potential to release volatile organic compounds (VOCs), according to the FDA.
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Monaghan Medical to Supply Medication Delivery, OPEP/PAP Devices to Children’s Hospital Association
Monaghan Medical Corp and the Children’s Hospital Association (CHA) have agreed to a three-year contract for Monaghan provide CHA members with devices in two categories: respiratory therapy medication delivery, and oscillatory positive expiratory pressure/positive airway pressure (OPEP/PAP).
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SleepRes Introduces V-Com, a Comfort Accessory to Soften CPAP Peak Inspiratory Flow
At SLEEP 2022, SleepRes LLC introduced the V-Com, a CPAP accessory that the company...
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Philips Provides Update on Medical Device Reports Linked to Recall
Philips Respironics: Submission of a medical device report itself is not evidence that the device caused or contributed to the adverse outcome or event.
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iNAP, Oral Negative Pressure Therapy for Sleep Apnea, Available in the United States
Somnics Health unveils iNAP, a new oral negative pressure therapy for obstructive sleep apnea (OSA) patients.
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Fisher & Paykel Launches Evora Full Mask
Fisher & Paykel Healthcare launches F&P Evora Full, a new full face CPAP mask, in the United States. Evora Full will be available for purchase by durable medical equipment companies starting May 9.
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As Little as Two Hours of PAP Therapy Has Sleep Benefits
Sleep apnea sufferers can gain health benefits from PAP therapy (positive airway pressure) in as little as two hours per night, according to a study presented at ATS 2022.
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Success of Noninvasive Respiratory Support in COVID Patients May Be Tied to Work of Breathing
Computational modeling shows that noninvasive respiratory support is more likely to be successful if it allows significant reductions in patients’ breathing efforts.
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