Model Number CA461NTS |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Cough (4457)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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The manufacturer received information in relation to a remstar pro c flex+ unit.The patient alleged that the user has coughs, and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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Device not returned to manufacturer.
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Event Description
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The manufacturer received information from hong kong in relation to a remstar pro c flex+ unit.The patient alleged that the user has coughs, and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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The manufacturer received information from hong kong in relation to a remstar pro c flex+ unit.The patient alleged that the user has coughs, and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In this report, these sections: describe event or problem (b5) and have been updated.
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Search Alerts/Recalls
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