Catalog Number 1755 |
Device Problem
Failure to Deliver (2338)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2017 |
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, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However material from our current inventory was functionally inspected and no issues were detected that can lead this customer complaint.Regarding similar complaints from this same issue a capa (b)(4) was generated in order to further investigate this issue.If the device sample becomes available at a later date this complaint will be updated.
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Event Description
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Customer complaint alleges that the staff reports the device with this lot number is defective.Customer alleges the device was tested, and "the neb just bubbled".Alleged malfunction reported as detected during pre-testing.No report of patient involvement.No report of patient harm or delay in treatment.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.The jet and jar were microscopically inspected and no defects or anomalies were observed.The remaining components were visually inspected and no defects or anomalies were observed.Functional testing was performed and 5cc of water was added to the returned nebulizer unit and the returned tubing was connected to an air flowmeter and the pressure was increased to 8lpm.A mist was produced from the chamber of the nebulizer and bubbling could not be confirmed.There were no functional issues found with the returned sample.The reported complaint of the nebulizer bubbled prior to used could not be confirmed through visual or functional inspection of the returned sample.The investigation of the returned sample found no evidence to suggest a manufacturing related cause as no functional issues were found with the returned sample.
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Event Description
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Customer complaint alleges that the staff reports the device with this lot number is defective.Customer alleges the device was tested, and "the neb just bubbled".Alleged malfunction reported as detected during pre-testing.No report of patient involvement.No report of patient harm or delay in treatment.
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Search Alerts/Recalls
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