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Model Number SC1200 |
Device Problem
Decrease in Pressure (1490)
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Patient Problems
Dyspnea (1816); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.
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Event Description
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Customer reports a cough, shortness of breath, sinus infection with md intervention requiring an inhaler and md advised customer to discontinue use of the device.
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Search Alerts/Recalls
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