mekcar
Philips (NYSE:PHG), which has been mired with recall of its respiratory devices, informed the the U.S. Food and Drug Administration (FDA) that its Respironics Trilogy ventilators reworked as a part of a June 2021 recall have two new potential issues.
The FDA said on Nov. 17 that the first issue was that the new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam, may potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure.
If the air pressure is significantly impacted, the device could issue a ventilator alarm, such as the Low Inspiratory Pressure alarm, the FDA added.
In addition, the FDA said that the second issue was that traces of particulate matter were found in the air pathway of some reworked ventilators.
Preliminary results showed PE-PUR and environmental debris in some samples, and in others only environmental debris, the U.S drug regulator noted.
The FDA said it has requested additional information from Philips to better understand the cause of the issues and to provide recommendations to patients and health care professionals.
The Amsterdam-based company has been grappling with the recall of several of its medical devices over safety concerns.
In its Q3 earnings release reported on Oct. 24, Philips said that until then about 4M replacement devices and repair kits had been produced, since the June 2021 recall. Philips Respironics had aimed to complete ~90% of the production and shipments to customers in 2022.
Philips also recorded €1.3B non-cash charge in Q3 for the impairment of goodwill of this business.
The recall has taken a toll on the company. In an effort to save cost and turnaround the company, new CEO Roy Jakobs, who had led the respiratory device recall initiatives, had also announced a workforce reduction of nearly 4K globally.
PHG -1.56% to $13.89 premarket Nov. 21