RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUM/CELL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR); PRODUCT CODE:BZD
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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Respiratory Tract Infection (2420); Nasal Obstruction (2466); Cough (4457); Swelling/ Edema (4577)
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Event Date 09/14/2021 |
Event Type
malfunction
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Event Description
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Athe 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 to sinus infection, cough, mouth swelling and nasal area closing. there was no report of patient harm or injury. there was no medical intervention required by the patient.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 sinus infection, cough, mouth swelling and nasal area closing 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 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.
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Manufacturer Narrative
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The manufacturer previously reported on this device in mdr 2518422-2022-102519.This report was submitted as a duplicate report of the previously submitted report.Section d1, d4 and h4 has been corrected/updated in tbhis report.
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Search Alerts/Recalls
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