smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS — recall Z-1274-2024
U.S. FDA — Device Enforcement · United States · 2024-02-07 · Class I
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Reported risk: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
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