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Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/09/2021 |
Event Type
Injury
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Event Description
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Customer reports worsening of preexisting copd, bronchitis, dyspnea with md intervention requiring a nebulizer, inhaler and advised to discontinue use of the device.
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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 has reviewed and made improvements to the complaint handling procedure to ensure compliance with fda regulations.These improvements were recommended because of an internal audit conducted by an external independent regulatory consultant.Soclean opened several capas to remediate the audit findings.Processes were revised to ensure reportable events were correctly identified and submitted to fda.Per fdas guidance, soclean is now reporting these events, which also includes retrospective items.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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Search Alerts/Recalls
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