The manufacturer became aware of an allegation of a thermal event occurring to the dc power supply and the dc power input of the continuous positive airway pressure (cpap) device.The user reported the unit stopped working, he noticed a burning electrical odor and a thermal event on the power supply at the power inlet port on the cpap.There was no patient harm or injury.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.
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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 became aware of an allegation of a thermal event occurring to the dc power supply and the dc power input of the continuous positive airway pressure (cpap) device.The user reported the unit stopped working, he noticed a burning electrical odor and a thermal event on the power supply at the power inlet port on the cpap.There was no patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device. the internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer and no error was found. the manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit was scrapped.Section a1, e1, h7, h9 were corrected and captured in this report.Section d8, d9, h2, h3 and h6 were updated.
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