A ventilator 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.There was no allegation of serious or permanent harm or injury.During the evaluation of the device at the third-party service center, visualization of foam particles was observed.In addition, it was found that the top enclosure was cracked, and the button was loose.The ui panel lines were replaced to resolve the issue.
|