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.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.There were no other discrepancies encountered in the internal inspection of the cycler.The cycler underwent and passed a safety analyzer and hipot test.There was no burning smell encountered during the investigation of the returned cycler.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 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 step 3 of setup of their peritoneal dialysis (pd) treatment.The patient noticed a burning smell coming from the back of the cycler close to the power switch after it went blank.The cycler was plugged into a power strip instead of the wall.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 completed treatment using manuals.There was no smoke of flames noted during the event.The cycler was returned to the manufacturer and a replacement cycler was provided and received.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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