RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11C |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Respiratory Tract Infection (2420); Cancer (3262); Epistaxis (4458)
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Event Date 02/28/2023 |
Event Type
malfunction
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Event Description
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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 cpa/bipap, and mechanical ventilator devices.The manufacturer received information alleging nasal/throat irritation or soreness, nose bleeds ,lung cancer.There was no report of serious harm or injury.The manufacturers investigation is ongoing.A follow-up report will be submitted when the manufacturers investigation is complete.
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Manufacturer Narrative
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The manufacturer was previously 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 has alleged visualization of particles.There was no report of patient harm or injury.In previous report, section e: initial reporter was incomplete.In this report, section e, g has been updated or corrected.
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Search Alerts/Recalls
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