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QUOTED. Katelyn Staub-Zamperini.

Executive Summary

Royal Philips may have been aware of foam degradation issues in its CPAP and BiPAP units for more than a year before beginning corrective actions, a document filed by US Food and Drug Administration investigator Katelyn Staub-Zamperini after a recent inspection claims.

“Firm management, including management with executive responsibility, were aware of potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators since at least 01/31/2020, or earlier, and implemented no further corrective actions until April 2021.” – Katelyn Staub-Zamperini, investigator, FDA

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