GE—Various Anesthesia Machines: May Produce Excessive Tidal Volumes under Certain Conditions
October 16, 2013 | Risk Management News
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In an October 4, 2013, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, GE states that when the anesthesia units below are operating in pressure control ventilation guarantee (PCV-VG) mode, the units may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume. The manufacturer has not confirmed the...