The manufacturer previously received information alleging a ventilator has black particles blowing out of the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Correction to section b5 describe event or problem: 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.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Correction to device problem code: changed to material integrity problem correction to h7: changed to recall and included recall number z-1974-2021.These corrections were necessary because the initial reporter did not understand that 'black' particles were part of the recall.
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