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 information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged hospitalization, breathing problem, low oxygen.There was no medical intervention 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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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 previously received information alleging hospitalization, breathing problem, low oxygen related to a cpap device's sound abatement foam.The reported event of having breathing problem, low oxygen was reviewed by the pms clinical expert.This event is assessed as not related to the device in this case.There is no report of the medical intervention that the patient has received at this time.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.Section d4 was missed to capture in previous report ,now it is corrected and updated in this report.
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