The FDA received an additional 6,000 medical device reports January 1, 2023-March 31, 2023, related to PE-PUR foam used in Philips ventilators and other devices recalled in June 2021.
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Philips Respironics issued an Urgent Medical Device Correction Letter regarding a problem for certain ventilators that could harm patients.
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Baxter has issued a medical device correction for the Life2000 Ventilation System, citing the potential for patient oxygen desaturation events due to improper use with third-party oxygen concentrators, which may cause patient harm or even death.
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Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.
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The FDA is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain ventilators.
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