This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes to the customer's reported problem were found during the device history record (dhr) review a product sample was received for evaluation.Visual and functional testing were performed.Visual inspection showed the pump was in good condition with no appearance of any physical damaged.A review of the event history log identified primary audible alarm post.During functional testing the reported issue was unable to be duplicated.The root cause of the issue could not be determined.A corrective and preventative action has been opened to address the reported issue.Replaced speaker and interconnect printed circuit board (pcb) as preventive measure.
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