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Model Number DSX1030H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Dry Mouth (4485)
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Event Date 01/25/2023 |
Event Type
malfunction
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Event Description
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The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The manufacturer received information alleging dry mouth , congestion.There was no report of serious harm or injury.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 was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The manufacturer received additional information alleging the patient also having nasal/throat irritation or soreness, difficulty breathing, nose dry.The medical intervention was not specified.Section g and h are updated in this report.
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Search Alerts/Recalls
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