Tag: ventilator

FDA Issues Early Alert for CooperSurgical Neonatal Ventilators Due to Connection Issue

24 Aug 2026 12:39 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding specific CooperSurgical neonatal CPAP ventilators. A loose connection could lead to loss of pressure, affecting patient oxygenation. CooperSurgical recommends removal of affected units; no serious injuries reported.

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FDA Issues Early Alert for Resmed Ventilators Over Leakage Risk

15 Jul 2026 6:33 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Resmed Astral 100 and 150 ventilators due to supercapacitor leakage, potentially causing therapy discontinuation. Five serious injuries are reported. Patients should not stop using devices without clinician instruction, as this issue could lead…

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