File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.The customer's existing, untreated copd is a significant factor to consider when assessing the reported cough.It's plausible that the cough is attributed to the copd condition.Furthermore, the customer's non-compliance with the device's proper maintenance guidelines may have contributed to the reported symptoms.Therefore, it's reasonable to conclude that the cough is likely not directly linked to the use of the soclean device.Reporting for due diligence.
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