RESPIRONICS, INC. DREAMSTATION AUTO BIPAP W/HUM/CELL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DSX700H11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464); Eye Pain (4467)
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Event Date 10/06/2021 |
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 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 phlegm, headache, cough, eye hurt.There was no report of serious 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 visualization of particles related to a bipap device's sound abatement foam.The patient has alleged phlegm, headache, cough, eye hurt.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.Section d1, d4 and h4 updated in this report.
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Search Alerts/Recalls
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