RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11 |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457)
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Event Date 10/19/2022 |
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/bipap) device's sound abatement foam.The patient has alleged particles in the device, cough, difficulty in breathing, nasal irritation, sore throat.There was no report of serious or permanent 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 previously reported a cpap device's sound abatement foam alleging particles in the device, cough, difficulty in breathing, nasal irritation, sore throat.The manufacturer has received the additional information alleging allergic reaction.There was no report of serious or permanent patient harm or injury.
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Search Alerts/Recalls
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