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 an allegation of a thermal event on a dreamstation auto cpap.The user reported the power supply caught on fire while in use.The user reported when she removed the dc power supply from the device power port a small flame shot out.The user blew the flame out.There was black smoke coming out of the power input on the machine related to a cpap device's sound abatement foam.There was no report of serious or permanent patient harm or injury.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 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.Section h9 corrected and h6 updated in this report.
|