Tag: ventilators
Philips updates vent instructions
November 25, 2024HME News Staff
WASHINGTON – Philips has updated its instructions for using Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin EVO and LifeVent EVO2 due to risk of inaccurate flow measurements caused by certain in-line nebulizer placements, according to the U.S. Food and Drug Administration. The company says to be aware that this issue may affect any device that has ever been used with in-line nebulizer treatments. The updated instructions include making sure all alarms are set appropriately and keeping...
Encore, Trace provide ‘ultimate easy button’
November 15, 2024Liz Beaulieu, Editor
LIVINGSTON, Tenn. – Encore Healthcare’s new strategic partnership with Trace Medical helps providers streamline the process of managing ventilator patients and improve their ability to deliver clinical outcomes, say Zach Gantt.
As part of the partnership, Encore Healthcare’s clinical management and compliance services are married with Trace Medical’s vent rental offering to form a one-stop solution called Vent360+.
“We’re working on several partnerships...
In brief: Vent correction, Medtrade ‘Insider,’ documentation update
October 9, 2024HME News Staff
CAMBRIDGE, Mass. – Philips Respironics has issued a voluntary correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators regarding the use of in-line nebulizers.
The company has determined that, in some circumstances, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of patient impact due to one or more of the following...
Philips issues correction for vents
October 8, 2024HME News Staff
CAMBRIDGE, Mass. – Philips Respironics has issued a voluntary correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators regarding the use of in-line nebulizers.
The company has determined that, in some circumstances, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of patient impact due to one or more of the following...
Sunset Healthcare launches pediatric line
October 8, 2024HME News Staff
CHICAGO – Sunset Healthcare Solutions has launched Brighter Pediatrics, a new product line dedicated to enhancing outcomes for home care providers serving pediatric patients. The line features pediatric NIV/CPAP masks, such as the Ray Pediatric Nasal and Full-Face Masks; an assortment of ventilator circuits and closed ventilation suction systems; and the Microflow Microdial Flowmeter which allows for precise and repeatable micro-step flow adjustments for infants requiring supplemental oxygen....
Encore Healthcare, Trace Medical jointly launch Vent360+
September 17, 2024HME News Staff
LIVINGSTON, Tenn. - Encore Healthcare and Trace Medical have formed a strategic partnership to launch Vent360+, a solution designed to simplify and streamline the provision of ventilator services for HME providers.
The one-stop solution integrates ventilator rentals, clinical management and compliance oversight – all under one convenient, all-inclusive monthly price.
“This partnership is a game-changer for the industry,” said Zach Gantt, president & CEO of Encore...
In brief: CPAP cleaners get warnings, ZOLL eyes Vyaire’s vent biz
September 4, 2024HME News Staff
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
The companies are:
Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology.
Natures...
ZOLL wins rights to Vyaire’s vent biz
September 3, 2024HME News Staff
CHELMSFORD, Mass. – ZOLL has announced it is the winning bidder in an auction to buy Vyaire Medical’s ventilator business as part of the company’s Chapter 11 bankruptcy proceedings. Completion of the acquisition is subject to court approval at a sale hearing and dependent on a successful closing that is anticipated to occur in the coming weeks. “Respiratory care has been central to ZOLL’s business strategy for many years,” said Jon Rennert, CEO of ZOLL....
Philips updates safety notice for certain BiPAPs
May 28, 2024HME News Staff
AMSTERDAM – Philips has provided an update on a field safety notice affecting certain Philips Respironics ventilators due to a potential device alarm-related issue.
The company first notified customers of the safety notice in March.
Philips provided the following update:
Philips Respironics notified customers of the BiPAP A30, BiPAP A40, BiPAP V30 and OmniLab Advanced Plus ventilators of a potential issue affecting approximately 100,000...
FDA announces Ventec vent recall
March 11, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has announced a recall of the Ventec Life Systems VOCSN patient breathing package (pediatric, active, oxygen, blue) for a manufacturing issue with its bonded spiral wrap. The recall, a Class I or most serious type of recall, is a correction, not a product removal. The issue: The spiral wrap detaching before or during ventilation, with the potential of compromising the structural integrity and functionality or of causing blockage, stoppage or...