Catalog Number 1755 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has not been received for evaluation by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.To perform a proper and thorough investigation to determine the source of defect reported it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed based only on the information provided.Root cause cannot be determined.If the sample becomes available this investigation will be updated with the evaluation results.
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Event Description
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Customer complaint alleges "it has been noticed that after the nebulizer treatment has started the solution leaks out of the nebulizer chamber." no patient harm reported.Patient condition reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned (1) one unit of catalog number 1755 iso-neb filtered nebulizer system for analysis.During the visual inspection no issues were observed.Functional testing was performed and the returned tubing was used to connect the nebulizer unit to the air flowmeter.5cc of water was added to the returned nebulizer unit and tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.During functional testing no leaks were observed from the nebulizer unit.The reported complaint that the nebulizer leaked could not be confirmed.During functional testing no leaks were observed from the nebulizer unit.The unit functioned as intended.
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Event Description
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Customer complaint alleges "it has been noticed that after the nebulizer treatment has started the solution leaks out of the nebulizer chamber." no patient harm reported.Patient condition reported as fine.
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Search Alerts/Recalls
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