The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged having kidneys issues and under dialysis, blood clots, skin peeling/infections, breathing problem, abnormal heart beat.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 of patient alleging to having kidneys issues, under dialysis, blood clots, skin peeling/infections, breathing problem and abnormal heart beat.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 a updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow up report will be filed.
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