Concomitant medical products: device evaluation summary: the pb840 ventilator 806 compressor was returned for failure investigation.It was reported that during use the pb840 ventilator 806 compressor caught fire and had burned.This caused extensive damage to some of the main components of the compressor.The fire was confined to the inside of the chamber.A visual inspection of the returned compressor was conducted, and the following was observed: the compressor external covers, while showing some evidence of thermal damage, were mostly intact.The damage was primarily centered in the lower right-hand side of the compressor.The source of the fire was most probably the motor start capacitor device as the surrounding area is where the most intense heat occurred.The right-hand side of the capacitor had fully disintegrated.A review of the compressor device history record (dhr) indicates that the compressor motor serial number: ((b)(4)) was installed in the compressor and manufactured in april 2004.The original compressor motor was still in place at the time of the reported event.The ventilator and compressor were designed with an expected life of twelve years.Details of the fault and compressor were forwarded to the vendor.They were unable to determine a root cause.If information is provided in the future, a supplemental report will be issued.
|