It was reported that, during assembly of cori, the 24 inch touchscreen monitor will turn on, yet nothing will appear on the screen.When they attempted to press "menu", nothing happened, and the monitor turns off on it¿s own.They ensured everything was plugged in appropriately (the tablet works and portrays what should be on the monitor screen), but they don't see anything on the monitor.No case reported; therefore, there was no patient involvement.
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H3, h6: the cori touchscreen, p/n rob10003, (b)(6), intended for used in treatment, was returned for evaluation.A relationship between the reported event and the device was not establish.The touchscreen pass all testing, no malfunction was observe.Touchscreen operated as design.In addition, a functional evaluation was performed on the part beyond the reported complaint.No additional functional non-conformances were identified.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, factor that may have contributed to the reported symptom may have been associated with internment electrical failure.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.No further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.
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