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The biomedical engineer (bme) reported that they keep getting this bed not ready error.The multiple patient receiver (org) would be rebooted and the unit would work for a few hours, but the issue would return.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2:, a6.B6:, b7.Attempt #1: 01/04/2024.Emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the multiple patient receiver (org).Central nurse's station: model: cns-6801a, sn: (b)(6).Device manufacturer date: 06/15/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 08/09/2013.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6), device manufacturer date: 05/13/2014.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 05/13/2014.Unique identifier (udi) #: 04931921115107 returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa, sn: (b)(6).Device manufacturer date: 04/22/2015.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6), device manufacturer date: 01/19/2017.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6), device manufacturer date: 09/21/2021.Unique identifier (udi) #: (b)(6), returned to nihon kohden: not returned.
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Details of complaint: the biomedical engineer (bme) reported that they kept getting a "bed not ready" error message.They rebooted the multiple patient receiver (org) and it would work for a few hours, then the issue would return.No patient harm was reported.Investigation summary: the org was sent in for evaluation and repair.The device, (org-9110a, sn: (b)(6)) was returned, cleaned, decontaminated, and evaluated.During the evaluation nihon kohden repair center (nk rc) was able to confirm the issue as the device was showing the "bed not ready" error message.Nk rc's evaluation found a programming / setup / configuration error, as there was a mismatch of the model number on the unit.The recommended repairs are to initialize the unit, reprogram, setup, and configure the device with the correct model number and recheck the network communication.We emailed the customer a quote for the recommended repairs.Once the repair approval and purchase order (po) is received from the customer, we will move forward with the recommended repairs, post repair testing, and then ship the unit back to the customer, once completed.Nk identified some possible org issues, which are not limited to user related error, incorrect settings, installation issues, file or software corruption, (due to a user relate error, such as an ungraceful exit or shutdown, which can cause corruption and settings related issues), battery issues, hardware / component failure issues, customer facility information technology (it) issues or network environmental issues (including power supply or power plug in outlet issues).A review of the device history for (org-9110a, sn: (b)(6)), did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.Moreover, this was found to be the only issue at the facility in the past three (3) years for this device and issue.However, a similar issue for a similar device was found under ticket (b)(4), for (org-9110a, sn: (b)(6)) for an error message being displayed.Under that ticket, nk was unable to confirm the reported issue as nk rc did not find any error messages on the device, but did find duplicate channels e602, which could have contributed to the registered bed error message.As such, this, and the similar issue under ticket (b)(4) are isolated issues.Therefore, a significant trend that would warrant any further corrective action has not been observed.D10: concomitant medical device: the following devices were used in conjunction with the multiple patient receiver (org): central nurse's station: model: cns-6801a.Sn: (b)(6).Device manufacturer date: 06/15/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 08/09/2013.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 05/13/2014.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 05/13/2014.Unique identifier (udi) #: (b)(6).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 04/22/2015.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 01/19/2017.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Telemetry transmitter: model: zm-531pa.Sn: (b)(6).Device manufacturer date: 09/21/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
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