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 patient alleges "constantly exhausted and doesn't feel rested the way that she did on the previous machine".The patient stated, " device gets so hot that it burned her wood on the nightstand.She has had to place towels there to be able to run the machine or touch it".There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|