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The customer reported that this gz transmitter is going blank on the central nurse's station (cns) and is discharging the patient.When this happens, data disappears as well.At the same time, the transmitter loses its name on the remote nurse's station (rns).No harm or injury occurred.
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The customer reported that this gz transmitter is going blank on the central nurse's station (cns) and is discharging the patient.When this happens, data disappears as well.At the same time, the transmitter loses its name on the remote nurse's station (rns).No harm or injury occurred.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 device information: concomitant medical device: the following device(s) were used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Rns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.
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Details of complaint: the customer reported that data from the gz transmitter was disappearing at the central nurse's station (cns) and the cns was discharging the patient.The transmitter's name (id) was also disappearing at the remote network station (rns).No patient harm or injury was reported.Investigation summary: nihon kohden (nk) was unable to confirm the reported issue, as the device was not returned for evaluation and despite follow up attempts, no further information was obtained.However, the root cause could possibly be related to a lack of user education, due to a user related error, such as incorrect settings or incorrect setup of the device and/or software during the installation and setup process.Variables such as incorrect settings and/or incorrect setup are known to cause or contribute to the reported issue.Moreover, no further similar issues have been reported for this device and/or facility since 01/21/2022, which could be an indication that the issue was resolved by the facility.The reported issue of admitting and/or discharging patient data and initial setup issues are typically due to, and are not limited to, user related errors, (which include incorrect software setup, lack of user education, incomplete installation, ip addressing issues, or the use of the incorrect software version and/or software compatibility issues, and hardware location issues).A serial number review of the complaint device history revealed there was only 1 (one) complaint found for this device.However, during trending for the facility, there were 2 (two) similar issues found for this issue (ticket 130586 reported on 01/21/2022 and ticket 128508, reported on 12/22/2021).Under the similar ticket 128508, use error was the cause of the issue, as the customer wasn't aware the bed id was set to auto.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 02/14/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/16/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Atteept # 3: 02/18/2022 emailed the customer via microsoft outlook for patient information: an "unknown" answer was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the gz transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni rns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni 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 h10 additional manufacturer narrative.
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