This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was unpacked, the tank was filled with water and the disposable was attached.But after the start button was pressed audio alarm came one and the device didn't work.After opening the device was discovered that the water sensor assembly was defective.The root cause of the reported issue was found to be a defective water sensor assembly.Actions were taken to mitigate the reported issue: the water sensor assembly, pump and safety and valve solenoid were replaced.
|