The biomedical engineer (bme) reported that a bedside monitor (bsm-6000) dropped off the central nurses station (cns).They were unsure when the bsm-6000 was removed from the cns.Biomed would like nkc to review the cns logs.No patient harm was reported.Nkc reviewed the logs, and it was assumed that the communication environment was not good, as they observed a log of failed wlan transport status control transmissions, etc.The following countermeasures are planned for cns-6801a software version 02-24; they believe they will be effective for this event.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 attempt # 1: 04/03/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 04/19/2024 emailed the bme for all information in the ni list above: the bme replied the patient information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bedside monitors (bsm-6000): model #: mu-671ra serial #: (b)(6).Device manufacturer data: 01/21/2017 (jan.21, 2017) unique identifier (udi) #: (b)(4).Returned to nihon kohden: na bedside monitors (bsm-1700): model #: bsm-1733a serial #: (b)(6).Device manufacturer data: 06/28/2016 (june 28, 2016) unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
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Details of complaint: the biomedical engineer (bme) reported that a bedside monitor (bsm-6000) dropped off the central nurses station (cns).They were unsure when the bsm-6000 was removed from the cns.Biomed would like nkc to review the cns logs.No patient harm was reported.Nkc reviewed the logs, and it was assumed that the communication environment was not good, as they observed a log of failed wireless local area network (wlan) transport status control transmissions, etc.The following countermeasures are planned for cns-6801a software version 02-24; they believe they will be effective for this event.Investigation summary: the bsm-6000 (bed id "vmc-c405") was dropped from this cns (serial (b)(6) , and another cns (serial (b)(6) was reported under notification (b)(6) , where the logs were reviewed by nkc.The cause of the issue was a software deficiency for the cns to retain the bsm data in case of an unstable bsm network connection during the wlan transport process.A review of the logs confirmed a failed wlan transport, which was presumed to be due to an unstable network environment.Nk service team and nk cits are working with the customer to assess their local network environment.Cns software version 02-24, will be released soon, includes improvements for the cns to retain the bsm information in case the network connection is lost during wlan transport.Nk plans to address this issue through software improvements.Nk will continue to monitor and trend similar complaints.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bedside monitors (bsm-6000): model #: mu-671ra, serial (b)(6) , device manufacturer data: 01/21/2017 (jan.21, 2017), unique identifier (udi) (b)(4), returned to nihon kohden: na.Bedside monitors (bsm-1700): model #: bsm-1733a, serial (b)(6), device manufacturer data: 06/28/2016 (june 28, 2016), unique identifier (udi) (b)(4) , returned to nihon kohden: na.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.
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