RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUM/CELL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Eye Burn (2523)
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Event Date 01/28/2022 |
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 device's sound abatement foam.The patient has alleged headaches, eye burn.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 alleged headaches, and eye burn related to a cpap device's sound abatement foam.There was no report of serious 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.Section h6 updated in this report.
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Manufacturer Narrative
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The manufacturer previously reported on this device in mdr 2518422-2022-71844.This report was submitted as a duplicate report of the previously submitted report.Section d1, d4 and h4 has been corrected/updated in this report.
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Search Alerts/Recalls
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