The biomedical engineer (bme) reported the g5 monitoring unit (g5) had vertical static waveforms during patient use.The bme instructed clinical staff to reboot the unit to resolve the issue.The bme was unable to duplicate the issue on a simulator.No patient harm was reported.The issue began after the software was upgraded to sw 02-28.Nk technical service account manager (tsam) pulled logs for nkc to review.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.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the g5 monitor: cns (b)(4), model #: pu-681ra, serial (b)(6), device manufacturer data: 24/01/2022 (jan.24, 2022), unique identifier (b)(4), returned to nihon kohden: na.
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