Catalog Number 8884717301 |
Device Problem
Air Leak (1008)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 07/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device sample is received by the manufacturer, but the investigation is not complete at this time.A device history record investigation was conducted and did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.
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Event Description
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The customer alleges an air leak from the device.
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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 no leaks were detected.The reported complaint of an air leakage from the product was not confirmed based upon the sample received.The returned breathing exerciser was able to pass a functional inspection when connected to vacuumed air.A dhr review was performed on the lot number with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned sample.No further action will be taken.
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Event Description
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The customer alleges an air leak from the device.
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Search Alerts/Recalls
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