Catalog Number 031-33J |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/04/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).No visual, functional or dimensional inspection can be performed since the device sample was not returned for evaluation.The device history record review showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.Based on similar complaints a capa file 40005320 was opened to further investigate this issue.According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.No conclusion can be established at this time based on the lack of device of sample.It is necessary to have physical sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.
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Event Description
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The customer alleges that the user was not able to connect the nebulizer adaptor with the flow meter.The screw-thread connector was stripped.
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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 observed that the internal threads of the adaptor were damaged.Functional testing could not be performed as the adaptor could not be connected correctly to the oxygen source due to the damage on the internal thread.Based on the visual exam, the reported complaint was confirmed.The root cause for the issue is the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.
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Event Description
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The customer alleges that the user was not able to connect the nebulizer adaptor with the flow meter.The screw-thread connector was stripped.
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Search Alerts/Recalls
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