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 no visualization of particles in the air path.The patient states, "that he developed sinusitis and that he has been trying to recover from it for the past year and a half.Symptoms have gotten better after stopping using the machine".The patient later stated in a gfe "initially the machine worked fine.After one month's use, i noticed nasal discharge, and constantly swallowing thick nasal discharge and constant coughing, and discharging phlegm throughout the day.Cough, runny nose, sinusitis, throat irritation, nose bleeds, frequent sneezing, phlegm expectorated from lungs, experienced nightly difficulty while sleeping, and constantly clearing throat 24 hours each day".My health conditions today have not significantly improved".There is no allegation of serious or permanent harm or injury.The patient stated, received treatment/medical intervention as the " va keeps prescribing numerous rx's" and that the diagnosis is "unknown".The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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