Model Number 0210 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Reportable as this delayed patient treatment.
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Event Description
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Nebulizer failures (medication bubbles but not aerosol and tube popping off).
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Event Description
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Nebulizer failures (medication bubbles but not aerosol and tube popping off).
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Manufacturer Narrative
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Reportable as this delayed patient treatment.Complaint not confirmed due to lack of a photo or return.Reviewed the dhr and no anomalies were found.Received samples and all nebulized as expected.One of the samples had an unrelated fault that instigated ncmr-02911.Reviewed the complaint history and there was only one previous complaint for this part.There is no trending.Performed risk analysis with rma-20013b and the related risk is 6/10, less than the capa initiation threshold of 8.Sent a resolution to the customer.
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Search Alerts/Recalls
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