The cycler was returned to the manufacturer for evaluation.A visual inspection of the exterior showed no signs of physical damage.The device was unable to be powered on.During examination, the issue was found to be that the cycler power supply module output voltage was 0 volts.After the power supply module was replaced, the cycler was able to turn on and was subjected to a simulated treatment test.The simulated treatment was performed and completed without any failures.There were no unusual odors observed during testing.The voltage check passed.An internal inspection of the cycler found no discrepancies.The power supply module that had to be replaced showed that the in-circuit fuse had blown.In addition, the c8 electrolytic capacitor in the power supply module was bulging and there was an observed oily, brownish film on the bracket underneath the power supply module.An investigation of the device history (dhr) records was conducted by the manufacturer.There were no issues found during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control testing met all requirements.The investigation into the cause of the reported incident was able to be confirmed.Although the evaluation of the returned device could not duplicate burning smell or smoke, it was confirmed that the cycler could not function properly as the capacitor on the power supply module had failed.
|