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 difficulty breathing and short of breath.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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A device was returned to a third-party service center 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 patient alleging an issue related to a cpap device 's sound abatement foam.The patient has alleged difficulty breathing and short of breath, hypertension, bladder issue, short term memory loss and can't fell her right hand.There was no medical intervention required by the patient.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Box and section has been corrected.Device serviced by a third-party service center.
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