The manufacturer received information alleging an issue related to a (cpap or bipap) device's sound abatement foam.Patient alleged of respiratory issues, lightheadedness, loss of smell & taste, dizziness, difficulty breathing/short of breath and also been using several steroid shots and antibiotics due to a severe cough and a thick mucus blockage.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
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 an issue related to a (cpap or bipap) device's sound abatement foam.The patient alleged of respiratory issues, lightheadedness, loss of smell & taste, dizziness, difficulty breathing/short of breath and also been using several steroid shots and antibiotics due to a severe cough and a thick mucus blockage.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.Section h6 updated in this report.
|