Catalog Number 1770 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.A device history record review shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.
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Event Description
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Customer complaint alleges the device is not producing mist.Alleged defect reported as detected during use.There was no report of patient harm.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the sample was found to be within specification.No issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.
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Event Description
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Customer complaint alleges the device is not producing mist.Alleged defect reported as detected during use.There was no report of patient harm.
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Search Alerts/Recalls
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