Case study-ventlab llc

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Reference no: EM133039693

Ventlab, LLC. Issues a Nationwide Recall of Ventlab Resuscitator Bags Due to Possible Health Risk

A. Use the risk management process to evaluate the following situation (use the steps and actually generate real suggestions for each step as if you are the risk manager

Ventlab LLC. of Grand Rapids, Michigan has initiated a voluntary medical device removal of a limited number of VentlabTM Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. The valves may stick due to incomplete curing during the manufacturing process. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation.

End users who have resuscitation bags within the lot numbers listed below should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.Tell risk manager, Roxana how would you briefly apply the four steps of the RMI process

Reference no: EM133039693

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