Details of the complaint: the biomedical engineer reported that they are having an issue with the arrythmia recall where they are unable to see the historical arrythmia data on the central nurse's station (cns).They stated that this is only happening with their telemetry transmitter system with the multiple patient receiver (orgs).They reported that the issue occurred (b)(6) 2021 1900 estimated time.They are not seeing any information on their arryhthmia recall tab and is rather concerned.Ts informed him that this was an issue that was ongoing and multiple facilities had the same issue.They understood.The customer later confirmed that they are able to view the arrythmia historical data in full disclosure and all the real time alarms are reporting correctly with all tones and banners coming across.(b)(6)2021, we received additional information from the customer that stated that this affected cardiac monitoring and that not being able to see (only the historical arrhythmia data from the arrhythmia recall feature) was not ideal for their needs (and affecting patient monitoring).No patient harm reported.Investigation conclusion: the reported device was not returned for evaluation.Nkc has determined that after 1/1/2021 when the data is transferred from the zm series through the org, the org receiver applies an incorrect date stamp to episodic transmitter data (i.E., arrhythmia recall data, b.St recall data, and c.Nibp measurement data).This date error is either carried over to the cns / rns or blocked so that the episodic data is missing depending on the model of the cns / rns.The root cause of this issue is software deficiency.Attempt #1 01/12/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded that this affected their telemetry systems but did not provide the specific org models and patient information.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1 01/12/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded that this affected their telemetry systems but did not provide the telemetry transmitter models and serial number information central nurse's station model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Model: cns-6201a, sn: (b)(6).Telemetry transmitters: model: ni.Sn: ni.
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