Other text: d3,g1, and g2 email is: regulatory.Responses@icumed.Com.Device evaluation: one device was returned for investigation.Under visual inspection we noticed that inflation line was detached from pilot balloon as reported by customer.The complaint was confirmed.What caused the failure of the supplied item could not be established.Dhr review not completed as the issue is not lot specific.The complaint issue continues to be monitored and suitable actions will be taken as appropriate.This issue will continue to be monitored and further actions taken accordingly.
|