Tag: Philips Respironics

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...

AMSTERDAM – Philips Respironics filed an additional 70,000 medical device reports (MDRs) with the U.S. Food and Drug Administration between April 2022 and October 2022, the company stated in a Nov. 22 update on its recall of certain CPAP, BiPAP and mechanical ventilator devices.  The vast majority of the 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury, the company stated.   “It is important to note that the submission...

AMSTERDAM – Philips has temporarily paused its remediation program for its Trilogy 100/200 ventilators while it investigates a limited number of complaints on remediated units.  “We anticipate a several week delay from our initial four- to six-week timeline in providing remediated devices back to our customers,” the company stated in a Nov. 7 update. “Remediating these devices in a timely manner is our top priority. In order to keep remediation progressing once our...

AMSTERDAM – Philips will reduce its workforce by about 4,000 roles globally, the company announced as part of its third quarter financial results. The immediate restructuring actions will result in EUR 300 million in charges in the coming quarters but will save EUR 300 million annually. “My immediate priority is to improve execution so that we can start rebuilding the trust of patients, consumers and customers, as well as shareholders and other stakeholders,” stated Roy Jakobs,...

PITTBURGH – Philips Respironics has agreed to pay more than $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to DME suppliers, the U.S. Department of Justice has announced.  The settlement resolves allegations that Respironics caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory related medical equipment that were false because the company provided...

AMSTERDAM, the Netherlands – Philips’ plan to remediate an additional 300,000 devices will push the completion date of its recall into 2023, but the company recorded additional provisions in the first quarter to speed up the process as much as it can.  Philips now expects to complete more than 90% of production and shipments to customers by the end of 2022, said Frans van Houten, CEO, during an April 25 conference call to discuss the company’s financial results for...

AMSTERDAM, the Netherlands – Philips Respironics recorded EUR 165 million in additional provisions related to its recall of certain CPAP devices in the first quarter of 2022, according to the company’s financial results.  The company recorded a EUR 65 million increase in the field action provision in the quarter to account for the higher expected volume of devices eligible for remediation and the higher communication costs. It recorded a further EUR 100 million provision...

AMSTERDAM, the Netherlands – Philips reported group sales of EUR 3.9 billion for the first quarter of 2022, with a 4% decline on the back of 9% growth in the same quarter last year.  The company says comparable order intake increased 5%, driven by the Diagnosis & Treatment and Hospital Patient Monitoring businesses.  “Our customers confirm the relevance of our strategy and portfolio, as evidenced by the further growth of our all-time-high order book,” said Frans...

AMSTERDAM, the Netherlands – Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit that controls the 35V power supply to the ventilator and alarm.  The company has identified that there is a possibility that effected vents may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown) and the patient may no longer receive respiratory assistance. It is advising...

NEW YORK – HME providers expect to shift an average of 58.4% of their Philips Respironics flow generator purchases and an average of 30.2% of their mask purchases to other companies due to the recall, according to the first quarter HME Sleep and Oxygen Survey from Needham.  That’s up from the 56% and 23.1%, respectively, reported in the third quarter survey.  “ResMed should gain market share over the (next 12 months),” the survey states. “Respondents...