The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap and mechanical ventilator devices.The manufacturer received information alleging sinus infections, inflammation in his eyes, cough, and headaches.There was no serious or permanent patient harm or injury.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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles.There was no report of serious or permanent harm or injury. the device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device. the internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit scrapped due to age.Section h4 was corrected in this report.
|