This belated mdr is being submitted as part of our remediation reports in response to the fda form 483 notification issued on june 4, 2014 by (b)(4) to ventlab, llc.This report consists of 48 mdr's.It was confirmed that the bang would not deflate because the pt valve had a stuck duckbill.The duckbill became unstuck during the investigation but it took 80cmh2o of pressure to open the valve.Additionally, ventlab performed quality trending, product investigation and corrective actions to solve the root causes.The solutions were implemented last year and a recall was initiated in may of this year.
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