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.There was no report of patient harm or injury.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation.During the evaluation, foam particles were observed.In addition, there was contamination from cigarette smoke or insect infestation.The device was scrapped.
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