FDA Raises Questions With Philips' Replacement Foam
Tuesday, November 16, 2021

BIRMINGHAM, Ala. (November 16, 2021)—During a recent plant inspection, the Food & Drug Administration (FDA) found that silicone-based foam Philips Respironics planned to use to repair recalled CPAP and ventilator devices had failed a safety test for volatile organic compounds.

Earlier this year, Philips initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to polyester-based polyurethane sound abatement foam used in the devices. This type of foam may break down and can result in serious injury. In September, the company announced the FDA had approved the repair and replace program for the devices.  

The facility inspection was in response to the initial recall, but the agency obtained additional documentation while conducting it that showed the silicone-based foam, which is currently used in a device marketed outside the United States had failed a single safety test. The FDA did not identify which device was affected.

More here:
https://www.homecaremag.com/ne...c_id=4680C7280956C7Y

Wow, it’s just keeps getting better and better for Philips

I’m so glad I ditched my Philips machine for a ResMed back when this first came out and I saw this Charlie Foxtrot coming.

I will bet you Philips ends up exiting the CPAP industry altogether.