(b)(6) reported that the central nurse's station (cns) randomly shut down on its own.(b)(6) tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.Evaluation summary: on (b)(6) 2024 pu-681ra sn (b)(6) was received at nihon kohden repair center (nkrc) and the unit was cleaned and decontaminated, no physical damage or fluid intrusion found in the unit.Unit was tested for the reported complaint of device randomly shutting down and issue was duplicated.Nkrc replaced two hard disc drives in the device tested per operator's manual for 24 hours and operates to manufacturer's specifications.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from biomed who stated "fortunately we did not have anyone on the monitoring system at the time it went down".He did not provide any further information requested information.
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(b)(6) reported that the central nurse's station (cns) randomly shut down on its own.(b)(6) tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.
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Biomedical engineer (bme) reported that the central nurse's station (cns) randomly shut down on its own.Bme tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.Evaluation summary: on (b)(6) 2024 pu-681ra sn (b)(6) was received at nihon kohden repair center (nkrc) and the unit was cleaned and decontaminated, no physical damage or fluid intrusion found in the unit.Unit was tested for the reported complaint of device randomly shutting down and issue was duplicated.Nkrc replaced two hard disc drives in the device tested per operator's manual for 24 hours and operates to manufacturer's specifications.Investigation summary: incident summary/troubleshooting/results: on (b)(6) 2023, the biomed reported that this central nurse's station (cns), (pu-681ra, serial number (b)(6) randomly shutdown early in the morning.The customer stated they tried to boot up the cns with one hard drive at a time but all they could hear was the internal fan blowing at full speed.The customer informed ts there was no kvm connected to the devices.The customer tried swapping out the monitor for a different one and the issue persisted.The customer requested to send the unit in for evaluation/repair.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Root cause analysis: upon evaluation from repair center, the device would randomly shut down.Therefore, the reported issue was confirmed and duplicated.Although a definitive root cause could not be determined, based on the available information the most likely root cause was due to defective/corrupt hard drives.To resolve the issue the unit was repaired, and the device was successfully shipped back to the customer.The unit was successfully shipped back to the customer.Device history: a serial number review of the reported device (pu-681ra, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Attempt # 1: 12/18/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 12/20/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from biomed who stated "fortunately we did not have anyone on the monitoring system at the time it went down".He did not provide any further information requested information.
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Biomedical engineer (bme) reported that the central nurse's station (cns) randomly shut down on its own.Bme tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.
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