The manufacturer received a voluntary medwatch (mw5145123) regarding the field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that a replacement dreamstation 2 auto cpap device contains black particles - a day old filter turned black.The patient alleges they waken "by a tickle in my nose all night which may be particles from the machine".There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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