Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.D4: complete udi - (b)(4).One device was received.No physical damage.The complaint was confirmed/duplicated.The o2 concentration is out of specification.The cause was the device was out of specification over time; the source was unknown.Recalibrated 02 concentration.Replaced o-rings, battery, and sintered filter.Recalibrated peep needle.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint., corrected data: h6.Health effects; corrected.
|