Plant investigation: 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 biomedical technician (biomed) reported noticing that a 2008k2 machine had internal wiring insulation that was breaking off and displayed signs of melting.The biomed stated that this issue could lead to conductivity and temperature issues, over time.To resolve the reported issue, the biomed replaced the conductivity sensor, and the two temperature sensors (temperature sensor 2 and temperature sensor 3).The wiring from all three components was exposed.There was no patient involvement associated with the reported issue.No sample was available to be returned for evaluation.
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