Catalog Number 41894 |
Device Problem
No Flow (2991)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/07/2016 |
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 device sample was not returned.No picture available for review.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available this investigation will be updated with the evaluation results.
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Event Description
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The customer alleges that the product did not steam as it should.The alleged issue was detected prior to patient 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 residue was found in the mask, jet, jar and cap.The returned sample was connected to a flowmeter and the airflow was increased to 8 lpm.A mist was produced from the chamber of the nebulizer.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
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Event Description
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The customer alleges that the product did not steam as it should.The alleged issue was detected prior to patient use.
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Search Alerts/Recalls
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