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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Conjunctivitis (1784); Dry Eye(s) (1814); Headache (1880); Tinnitus (2103); Dizziness (2194); Sinus Perforation (2277); Respiratory Tract Infection (2420); Cough (4457); Respiratory Insufficiency (4462); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/16/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging,respiratory issues, recurrent sinusitis, persistent sinus pressure and congestion in his head,chest ears and nose, dry eye syndrome, irritation of eyes, sinus infections, severe congestion, permanent hearing loss, tinnitus, airway irritation, persistent cough, dizziness, headaches and severe inflammation in his ears, nose and throat, related to a cpap device's sound abatement foam.There was no report of patient 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 previously received information alleging respiratory issues,recurrent sinusitis,persistent sinus pressure and congestion in his head,chest ears and nose,dry eye syndrome,irritation of eyes,sinus infections,severe congestion, permanent hearing loss,tinnitus,airway irritation,persistent cough,dizziness,headaches and severe inflammation in his ears,nose and throat related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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Search Alerts/Recalls
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