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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Vertigo (2134); Dizziness (2194); Epistaxis (4458); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/20/2021 |
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 having horrible migrains, chest pressure, nose bleeds, vertigo, dizziness.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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In previous report, section b1 is incorrectly reported and its corrected in this report (product problem).
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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 alleged having horrible migrains, chest pressure, nose bleeds, vertigo, dizziness, and nasal/throat irritation or soreness related to a cpap device's sound abatement foam.There was no report of serious or permanent 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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