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.An internal inspection of the cycler found evidence of an internal short present on transformer (t1) of the inverter board.There was no burning smell present.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed, and the touch screen became operational.Removed functioning inverter board from the touch screen at the completion of the investigation.An internal visual inspection of the returned cycler encountered no other discrepancies.A review of the device manufacturing records was conducted by the manufacturer.In addition, a device history record (dhr) review was performed and the following results were found: a test and calibration: blank display send to rework, 01/25/2019 rework: confirmed blank display due to bad front panel.Replaced front panel now display functions properly.Return to test & calibration, 01/25/2019, test & calibration: passed 01/28/2019 and post accelerated test: passed 01/29/2019.In addition, the results were verified with an in-progress and final quality control (qc) testing.Upon completion of the evaluation, the reported issue was confirmed, and the cause was determined to be an internal short on the inverter board.The cycler was refurbished following the evaluation.
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It was reported that the screen of a patient¿s liberty select cycler went blank during their peritoneal dialysis (pd) treatment.The patient noticed a burning smell from the cycler.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient did not complete treatment.The cycler was returned to the manufacturer and a replacement cycler was provided and received.The patient reported that there was no smoke or spark observed.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board had an internal short.
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