Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.The device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.
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A user facility biomedical technician reported a fresenius 2008t machine with burned and melted power logic boards.The issue was found while servicing the machine after the machine made a loud popping sound and gave off a burned smell, after which the display screen went blank.The biomed replaced the burned and melted power logic board with a new power logic board, which also failed and had evidence of melting.The biomed replaced the 24v cable harness from the card cage to the power supply, along with a new power logic board to resolve the issue and return the machine to service.It was confirmed there was no patient involvement.It was confirmed that the sample parts are available for return to the manufacturer.Additional information was requested, but was not provided.If additional information is received, a supplemental report will be submitted.
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