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 device over heat at night, device throws hot air to face almost burning, device/power cord too hot to touch, burning odor and particle in air chamber related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Corrected information provided in b5 and h6, the information (the manufacturer received information alleging device/power cord too hot to touch, burning odor and particle in air chamber related to a bipap device') was not included in initial report.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.
|