Catalog Number 403128 |
Device Problems
Leak/Splash (1354); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned to the, manufacturer at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation to confirm the alleged defect and determine the root cause.If the device sample becomes available this report will be updated with the evaluation results.
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Event Description
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Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.It was noticed, however, that the snap on adaptor was not returned with the device.It was not possible to perform the oxygen entrainment test as the adaptor was not returned.One component part number tfx-001743 (adaptor, snap-on flowmeter resin re-0042) lot number 1-0318741 was taken from the assembly line and assembled on the sample.Oxygen entrainment testing was then performed on the sample.No functional issues were encountered.The complaint could not be confirmed as the adaptor was not returned with the device.
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Event Description
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Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.
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Search Alerts/Recalls
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