No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The drive gas check valve could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle.If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.Ge healthcare (gehc) is initiating and will be reporting a field modification for this issue per 21 cfr 806.The gehc internal field modification number is (b)(4).
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