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Device Problem
Degraded (1153)
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Patient Problems
Chest Pain (1776); Renal Failure (2041); Respiratory Tract Infection (2420); Liver Failure (4492)
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Event Date 09/09/2021 |
Event Type
Death
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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 became degraded and caused chest pressure, sinus infections and kidney/liver failure that resulted in death.The patient's spouse did not report the patient to receive medical intervention.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 reported an alleging an issue related to a cpap device's sound abatement foam became degraded and caused chest pressure, sinus infections and kidney/liver failure that resulted in death.The patient's spouse did not report the patient to receive medical intervention.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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Search Alerts/Recalls
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