Plant investigation: no parts were returned to the manufacturer for physical evaluation.
A fresenius (b)(4) technician performed an onsite investigation and resolved the issue by replacing the damaged power rocker switch and shorted fuses.
A records review was performed on the reported serial number.
An investigation of the device manufacturing records was conducted by the manufacturer.
There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.
In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.
The investigation into the cause of the reported problem was able to be confirmed.
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