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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dizziness (2194); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/13/2021 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of black particles in the airway.Also alleged tremors, dry sinuses, burning, shore throat, dizzy, eye irritation, coughing, watery eyes.There was no report of serious or permanent 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 information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of black particles in the airway.Also alleged tremors,dry sinuses,burning,shore throat,dizzy,eye irritation,coughing,watery eyes.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.
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Search Alerts/Recalls
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