Catalog Number 031-33J |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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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The complaint is reported as: "the user found air seemed to be leaking from the connecting part assembly to the flowmeter before use on a patient.Therefore, a new unit was used instead." no patient involvement.
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Event Description
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The complaint is reported as: "the user found air seemed to be leaking from the connecting part assembly to the flowmeter before use on a patient.Therefore, a new unit was used instead." no patient involvement.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the puncture pin was missing.No other issues were found.In order to perform a functional inspection, the missing component (puncture pin) had to be assembled to the sample.The sample was then tested on the oxygen entrainment test with no functional issues.As an additional test the sample was tested on the oxygen entrainment test using a bottle of sterile water connected to the nebulizer adaptor and no air leaks were detected.
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Search Alerts/Recalls
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