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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Fatigue (1849); Headache (1880); Red Eye(s) (2038); Dizziness (2194); Sore Throat (2396); Respiratory Tract Infection (2420); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
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 particles.There is no allegation 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 previously receiving information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received additional information that gray particle in the chamber and alleging the patient also having grit in eyes, fatigue, short of breathe, lightheaded, headache, nasal/ throat irritation or soreness.The medical intervention was not specified.Section h2, h6 are correctly updated in this report.
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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 gray particle in the chamber related to a cpap device's sound abatement foam.Also the patient alleging having grit in eyes, fatigue, short of breathe, lightheaded, headache, nasal/ throat irritation or soreness.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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