Tag: Philips Respironics

WASHINGTON – The U.S. Food and Drug Administration on June 27 highlighted updated use instructions from Philips Respironics for its BiPAP V30, BiPAP A30 and BiPAP A40 ventilators due to potential interruptions and/or loss of therapy.  Philips has updated the use instructions for the vents due to a potential failure in the ventilator inoperative alarm, which can cause therapy interruption or loss.  New instructions  If interruptions of therapy can be tolerated and...

MURRYSVILLE, Pa. – Philips Respironics will cut 300 manufacturing jobs in Western Pennsylvania and relocate approximately 500 workers from its Pittsburgh headquarters to its two major plants in the nearby suburbs, according to local news reports.  Starting in the fourth quarter of 2024, the company will move workers to its centers in Murrysville and New Kensington, a move that is expected to take two years, according to the Pittsburgh Post-Gazette.  The company said it will...

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...

YARMOUTH, Maine – With its Trilogy EVO considered the standard bearer, the decision by Philips to exit the home ventilator market in the U.S. is a tough hit, but “business goes on,” say industry players.  “Philips was the industry leader for NIV therapy,” said Elliot Campbell, executive vice president and chief commercial officer for Whitmore Lake, Mich.-based Trace Medical, a supplier of rental ventilators nationally. “But our customers have been in flux...

ORLANDO, Fla. – Rotech Healthcare on Feb. 23 provided notification of a recent privacy incident experienced by Philips Respironics that may have impacted certain information of patients who purchased Philips sleep and respiratory devices from Rotech.  “Although Rotech is unaware of any misuse of information resulting from this event, we are providing this notice in an abundance of caution,” the company stated on its website.  When reached for comment, a spokesman...

YARMOUTH, Maine – Even after enduring the roller-coaster of doing business with Philips Respironics the past few years, providers were still shocked by the company’s recent announcement that it would stop selling certain respiratory products.  Philips on Jan. 25 announced that it would discontinue selling 19 products in the U.S., including items subject to a recall, like the Trilogy 100/200/202 portable home ventilators. The company will service many of the products until Jan....

YARMOUTH, Maine – The decision by Philips to discontinue its line of oxygen concentrators in the U.S. will leave a significant gap in the market, but manufacturers say they’re ramping up to meet increased demand, with lessons learned from the COVID-19 pandemic and the CPAP recall.  Just prior to announcing it had agreed on the terms of a consent decree related to the recall, Philips announced on Jan. 25 that it was discontinuing sales for 19 products, including the EverFlo home...

AMSTERDAM – Philips has agreed on the terms of a multi-year consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory care devices, providing clarity and a roadmap to demonstrate compliance and to restore the business, the company says.  In the U.S., Respironics will continue to service sleep and respiratory care devices already with health care providers and patients, and supply accessories (including patient...

AMSTERDAM – Philips Respironics has released a list of 19 sleep and respiratory products that it will stop selling in the United States as soon as this month, including the EverFlo home oxygen system and the Trilogy EVO and EV300 home ventilators.  “We have streamlined our portfolio to enable us to focus on programs that are best suited to changing market dynamics and will most effectively serve patients and customers in the future,” the company states on its website. “In...

AMSTERDAM – The U.S. Food and Drug Administration yesterday issued a safety communication to inform users of possible thermal issues with the Philips Respironics DreamStation 2 CPAP machine and to advise them to monitor the machines for signs of overheating.   The FDA recently received medical device reports (MDRs) associated with issues like fire, smoke, burns and other signs of overheating while using the machine. The agency is in ongoing discussions with Philips about...