The biomedical engineer reported that the gz transmitter was not alarming for a low battery.They stated that the gz did not beep, indicating it was going to be powering off.Biomed stated that the customer would like nihon kohden to review the logs.Not in patient use.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.D10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Attempt # 1: 05/12/2023 emailed the customer for concomitant medical device: no reply was received.Attempt # 2: 05/15/2023 emailed the customer for concomitant medical device: no reply was received.Attempt # 3: 05/16/2023 emailed the customer for concomitant medical device: no reply was received.
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