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 pressure issues.The patient alleges trouble breathing.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The patient states that they no longer have the device and it is not available to be sent to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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