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 07/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the alleged defect was not provided.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of the product 031-33j batch number 74d1601769 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.No conclusion can be established at this time based on the lack of the 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.Personnel from the assembly line were notified of this issue.
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Event Description
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The customer alleges that the adaptor would not connect with the oxygen flowmeter properly.A new adaptor was obtained for use.
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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.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be 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 adaptor would not connect with the oxygen flowmeter properly.A new adaptor was obtained for use.
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Search Alerts/Recalls
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