Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.Upon power up, the cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel touch screen remained blank.It was identified that the cause for the blank screen was due to a burnt transformer on the inverter board.The inverter board is located on the rear of the touch screen.A known good inverter board was installed, and the display became fully operational.The simulated treatment pre- accelerated stress test (ast) 15-minute 1000 ml test passed.An internal visual inspection of the returned cycler encountered no other discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed, and the cause was determined to be a burnt transformer on the inverter board.The cycler was refurbished following the evaluation.
|