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Catalog Number 031-33J |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available for review.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of device sample.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line will be notified for awareness.
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Event Description
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The customer alleges that the connection between the adaptor and oxygen flowmeter was unstable so the aquapak bottle, aquatherm, and adaptor fell from the flowmeter.The alleged issue occurred prior to use.
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Manufacturer Narrative
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(b)(4).A visual inspection was conducted on the returned sample.Functional testing (oxygen entrainment testing) could not be performed due to missing component from the assembly.General pull and push test procedures were performed.Attempts to duplicate failure mode were performed.There are two ways to duplicate the failure mode of the loose or missing component (b)(4) from the assembly (by overtighten the nut adaptor onto the flow meter and by manipulating the assembly connection).However during testing, no observation of wear or damages on component (b)(4) was noted.A dhr review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed, since the sample was received without p/n (b)(4).Therefore, there is no sufficient evidence to assure this issue was originated during the manufacturing assembly process.The root cause for the condition reported could not be identified.However, the personnel from the adaptor assembly line were notified on (b)(6) 2017 for awareness.
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Event Description
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The customer alleges that the connection between the adaptor and oxygen flowmeter was unstable so the aquapak bottle, aquatherm, and adaptor fell from the flowmeter.The alleged issue occurred prior to use.
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Search Alerts/Recalls
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