Continuation of d11: (b)(4).One unit of catalog number 1613 (ventilator tubing set, long length) was received for analysis.The closure of the temperature port was inspected.The port was closed with the attached closure and no issues were observed.The temperature port was dimensionally inspected and no issues were observed.Functional testing was then performed and the sample passed the leak test.The temperature port was closed and remained closed without issues during the test.After functional testing the temperature port stayed closed for more than 24 hours and no issues was encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.
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