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 (mw5147425).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging patient seen by pulmonologist, he ran a series of tests and then diagnosed with pulmonary fibrosis, restrictive lung disease, and interstitial lung disease.There was report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972,z-1973, and z-1974.H3 other text : device not returned to manufacturer.
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