The manufacturer received information alleging black particles in tubing/chamber related to the cpap device's sound abatement foam.User also states difficulty breathing, shortness of breath, throat mucus.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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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 an alleging difficulty breathing, shortness of breath, throat mucus related to a cpap device's sound abatement foam.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.
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