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Details of complaint: the biomedical engineer (bme) reported on 11/20/2023 that the central nurse's station (cns) was showing comm loss for a few telemetry transmitters, all connected to the same multiple patient receiver (org).They rebooted the org and reseated the ethernet cable.On 12/07/2023, the customer stated were still getting comm loss.No patient harm was reported.Investigation summary: 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 communication loss for a few devices on the cns.Nk rc's evaluation found there was excessive noise on three (3) channel receivers (part number: zr-920p-ft, quantity, three (3) each), and were recommended to be replaced.Nk rc also updated the software to (version 05-01).Nk rc confirmed the issue was attributed to damage to the receiver components, likely due to mishandling, customer abuse, and/or wear and tear damage, leading to the reported issue.In this case, the device had aged approximately eight (8) years and ten (10) months, as the device was installed at the facility on 04/23/2015.The warranty expired on 04/21/2022, indicating the device was susceptible to wear and tear damage.Nk communicated the evaluation results and the cost of the repairs to the customer, and the customer has not yet approved the purchase order (po) and repairs.Once the po is received, nk rc will move forward with the repairs, if applicable.Despite follow-up attempts, no further information was received.Some potential causes/mitigation of the reported issues, are listed below and 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 it issues or network environmental issues (including power supply or power plug in outlet issues).Issues with org devices can be mitigated by our nk ts team working with the customer, or the customer working with their it department to resolve such issues.If the issue is determined to be related to damage, the damaged device, component and or accessories/cable or hardware used with the device, can be either repaired or replaced to resolve any damage issues.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt #1.01/03/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/05/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 02/27/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: central nurse's station: model: cns-6201a sn: (b)(6) device manufacturer date: 12/09/2014.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Zm telemetry transmitters: model: ni sn: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: not returned additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
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