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 dreamstation auto cpap device's sound abatement foam.The patient alleged problems with inhaling when using the device.There was no report of serious or permanent patient harm or injury.The device was returned to a third-party service center.The internal part of the device was inspected visually.Evaluation result confirmed no evidence of visible foam degradation.The unit passed final test.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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