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 voluntary medwatch (mw5153081).The manufacturer received information alleging an issue related to a dreamstation 1 cpap device's sound abatement foam.The patient has alleged device was so loud and noisy, that patient was not able to sleep.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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