Catalog Number 1613 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Customer reported the temperature probe port is not staying capped and therefore won't seal the ventilator circuit.The issue was detected prior to patient use.
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Event Description
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Customer reported the temperature probe port is not staying capped and therefore won't seal the ventilator circuit.The issue was detected prior to patient use.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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