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The nurse reported that a patient on the gz telemetry transmitter was being discharged from the central nurse's station (cns) without user intervention.(b)(6) 2022 at 23:09, no one was in the room with the patient, and they noticed the telemetry transmitter was discharged from the cns.All data was lost.(b)(6) 2022 at 00:51, no one was in the room with the patient, and they noticed the telemetry transmitter was discharged from the cns.All data was lost.(b)(6) 2022 at 06:05, the staff was in the room at the time and saw it discharge.All data lost.They swapped out telemetry transmitter for another unit and have not had any issues.They were not able to collect logs from the gz telemetry transmitter to see what was happening on the unit itself.No patient harm was reported.
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The nurse reported that a patient on the gz telemetry transmitter was being discharged from the central nurse's station (cns) without user intervention.(b)(6) 2022 at 23:09, no one was in the room with the patient, and they noticed the telemetry transmitter was discharged from the cns.All data was lost.(b)(6) 2022 at 00:51, no one was in the room with the patient, and they noticed the telemetry transmitter was discharged from the cns.All data was lost.(b)(6) 2022 at 06:05, the staff was in the room at the time and saw it discharge.All data lost.They swapped it out for another telemetry transmitter and have not had any issues.No patient harm was reported.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.Attempt #1 04/22/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient information.Additional device information concomitant medical devices: the following device(s) were being used in conjunction with the gz telemetry transmitter.Central nurse's station: model: cns-6801a sn: (b)(4).Device manufacturer date: 09/07/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
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Details of complaint: the nurse reported that a gz telemetry transmitter was discharged from the central nurse's station (cns), 3 separate times, without user intervention.All patient data was lost.No patient harm was reported.Investigation summary: the procedures for admitting, discharging, and transferring are provided in the operator's manual, chapter 4 (admitting and discharging patients).Device logs were sent to nihon kohden corporation for analysis.We confirmed the corresponding gz was 129-6e and the events had happened three times as follow: 4/12 23:09 4/13 00:51 4/13 06:05.Through our cns log analysis, we found the patient was admitted and discharged with the gz during the following time period: (b)(6) 2022 23:05:23, (nkcns-9701, 2001, admitted, bed, 129-6e, patient), (b)(6) 2022 23:05:17, (nkcns-9701, 2001, discharged, bed, 129-6e, patient).However, we were unable to confirm the log of admission/discharge operations in the cns.As a result of the gz log confirmation, we found that the discharge operation was performed from gz.(b)(6) 2022 23:05:16 (operation status change 7,0 *).The admission operation is "operation status change 7,1." the customer was advised that we were able to confirm that the discharge operation was carried out with the gz.They were advised to use the key locking function to prevent erroneous operation.The cause of the reported issue is use error.There is no indication that the cns nor the gz device had malfunctioned.A service history for this gz device shows this is an isolated incident, with no recurrence history.The following fields contain no information (ni), as an attempt to obtain the information was made, but was not provided.Attempt #1 04/22/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient information.Additional device information: d10: concomitant medical device: the following device was used in conjunction with the gz telemetry transmitter.Central nurse's station (cns): model: cns-6801a.Sn: (b)(6).Device manufacturer date: 09/07/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
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