The customer reported that a patient passed away while on this gz transmitter and the staff claims that there were no alarms.The customer believes that the battery ran out on the unit while the patient was in the shower and the staff was unaware when they put the device back on the patient to monitor after.The customer is not sure if the unit was in monitor mode at the time of the incident.The customer does not believe that the device is at fault.The customer could not provide the central nurse's station (cns) information; however, the customer collected the logs from the transmitter.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 information were made, but not provided: a2 - a6 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns:.
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