Model Number ORG-9110A |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme) reported that there was communication loss across a segment.The multiple patient receiver (org) required to monitor the telemetry transmitter was rebooted and the communication loss message went away.The customer stated that the communication loss was across telemetry devices 90 - 97.No patient harm 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 additional model information: 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) for the telemetry transmitters, as attempts to obtain information were made but information was not provided.Central nurse's station: model: cns-6201a, sn: (b)(4).Telemetry transmitter: model: ni, sn: ni.
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Event Description
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The biomedical engineer (bme) reported that there was communication loss across a segment.The multiple patient receiver (org) required to monitor the telemetry transmitter was rebooted and the communication loss message went away.The customer stated that the communication loss was across telemetry devices 90 - 97.No patient harm reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported there was comm loss across one segment of the telemetry transmitters, on devices 90 - 97.The multiple patient receiver (org) was rebooted and the comm loss error message went away.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: as the device was not returned for evaluation, a root cause cannot be determined.The customer called nihon kohden (nk) requesting assistance in changing channels for the telemetry transmitter devices used with the reported org.It is likely that the telemetry devices were using duplicate channels, which would result in communication loss.The customer was educated by nihon kohden tech support (nk ts) on how to change the channels.No further issues were reported with the org relating to communication loss.Root cause is likely related to duplicate channels due to use error or customer education.
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Event Description
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The biomedical engineer (bme) reported there was comm loss across one segment of the telemetry transmitters, on devices 90 - 97.The multiple patient receiver (org) was rebooted and the comm loss error message went away.No patient harm was reported.
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Search Alerts/Recalls
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