CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
|
Back to Search Results |
|
Catalog Number RTLR180343 |
Device Problem
Thermal Decomposition of Device (1071)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 04/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 found fuse f1 was blown.It was identified that the cause for the blank screen was due to an internal short 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.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 an internal short on the transformer on the inverter board.The cycler was refurbished following the evaluation.
|
|
Event Description
|
It was reported that the screen of a patient¿s liberty select cycler went blank upon power up.The cycler was plugged into a working outlet.The ok and stop keys were on.The cycler was rebooted, however the screen remained blank.The patient touched the screen and the cycler beeped, however the screen did not respond.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.Additional information was requested, however to date has not been provided.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short was identified on the inverter board.
|
|
Search Alerts/Recalls
|
|
|