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 skin irritation and rash.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to a third-party service center.During the evaluation of the device at the third-party service center, the device was visually inspected and found no problems and was unable to confirm the patients complaint.The device was scrapped.
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