The manufacturer received information alleging a ventilator has black particles blowing out of the device and the device is noisy.The patient alleges dizziness, kidney dysfunction, and dry mouth.No medical intervention was specified 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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The manufacturer previously received information alleging a ventilator has black particles blowing out of the device and the device is noisy.The patient alleges dizziness, kidney dysfunction, and dry mouth.No medical intervention was specified by the patient.Correction to section 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.The patient alleges dizziness, kidney dysfunction, and dry mouth.No medical intervention was specified by the patient.Correction to device problem code: changed to material integrity problem-degraded-n/a correction to 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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