This report is based solely on the customer's reported issue.The device was requested to be returned and has not been received for evaluation.A dhr review could not be performed as the device serial number was not provided.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file #(b)(4).
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This report is based on a medsun report (b)(4) received july 13, 2021.Customer reported the blender on the extracorporeal membrane oxygenation machine provides oxygen to the oxygenator.The patient was cannulated and the post arterial blood gas (abg) measurement normally run greater than 400.This post abg remained in the high 180's.The patient desaturated and required more ventilation support.After switching out the blenders, the patient post abg was more in the normal range.
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