A device was returned to a third-party service center in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the third-party service center, the device was visually inspected.The complaint was confirmed and there are foam particles visible along with scratches on the top enclosure panel.Corrective action was taken - the top enclosure pane was replaced along with the operating software was upgraded.The device passed the final test.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.
|