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.Customer returned all product for investigation and malfunction was confirmed.Breakdown: (b)(4) units opened immediately, (b)(4) opened with less than 40cmh2o pressure, and (b)(4) opened with more than 40cmh2o of pressure.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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