The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap and mechanical ventilator devices.The manufacturer received information alleging heart feels funny, lot of lung issues, a lot of er visits, chest feel tight, difficulty breathing/short of breath.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 to cpap device's sound abatement foam.The patient alleged heart feels funny, lot of lung issues, a lot of er visits, chest feel tight, difficulty breathing/short of breath.This notification was reviewed by the pms clinical expert due to patient reporting of lung issues, heart feels funny, chest feels tight and difficulty of breathing/shortness of breath.The reported events of heart feels funny and chest feels tight may be related to a product problem and/or user error.Additionally, the reported complaints could also be explained by disease or underlying condition/past medical history.Base on the available information at the time of the review, the device may have caused or contributed to the reported events.However, further investigation is warranted to confirm any definitive causal relationship between the event and possible failure, malfunction, improper or inadequate design, manufacture, labeling 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 was updated in this report.
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