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 respiratory issues and bronchitis.There is no allegation of serious or permanent harm or injury.The patient saw their healthcare provider who advised the patient that it was okay to continue to use.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|