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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Cyst(s) (1800); Dry Eye(s) (1814); Headache (1880); Unspecified Infection (1930); Respiratory Tract Infection (2420); Cough (4457); Eye Infections (4466)
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Event Date 12/12/2019 |
Event Type
Injury
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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.Patient alleged of visualization of particles in reservoir of device and also alleged of constant sinus infections in nasal passage which need surgery, cough, dizziness, throat irritation, eye and nose irritation, headache, lung infection.Patient also had a cat scan which confirmed cysts in nasal cavity.Patient had a medical intervention which was surgery and antibiotic and steroid medication.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 visualization of particles related to a cpap device's sound abatement foam.The patient also alleged to constant sinus infections in nasal passage which need surgery, cough, dizziness, throat irritation, eye and nose irritation, headache, lung infection.Patient also had a cat scan which confirmed cysts in nasal cavity.The above reported event is assessed as possibly related to the device in this case.Hence, the device may have cause or contribute to the alleged serious injury.Patient had a medical intervention which was surgery and antibiotic and steroid medication.Customer declined to respond to the gfe related questions and terminated the call.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.Section h6 updated in this report.
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Search Alerts/Recalls
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