Model Number ORG-9110A |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).It will drop into a small bout of "signal loss" roughly every 10 minutes, or it will go into a longer period of signal loss for up to 3 minutes.The bed tile will show "cannot analyze" on the cns screen, then the data goes away in full disclosure, and the event list shows "signal loss" for that period of missing data.No sawtooth waves in full disclosure or on the screen.The tile will show as completely blank on the cns screen.The cns will show a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.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 device information: concomitant medical device: the following devices were being used in conjunction with the org.The serial numbers for the telemetry transmitters were not provided and therefore listed as no information (ni).Central nurse's station: model: cns-6801a, sn: (b)(4).Telemetry transmitter: model: zm-531pa, sn: ni.
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Event Description
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The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).It will drop into a small bout of "signal loss" roughly every 10 minutes, or it will go into a longer period of signal loss for up to 3 minutes.The bed tile will show "cannot analyze" on the cns screen, then the data goes away in full disclosure, and the event list shows "signal loss" for that period of missing data.No sawtooth waves in full disclosure or on the screen.The tile will show as completely blank on the cns screen.The cns will show a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer reported that there was intermittent signal loss displayed at the central nurse's station (cns).It would drop into a small bout of "signal loss" roughly every 10 minutes, or it would go into a longer period of signal loss for up to 3 minutes.The bed tile would show "cannot analyze" on the cns screen, then the data would disappear in full disclosure, and the event list showed "signal loss" for that period of missing data.The cns displayed a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.Service requested / performed: evaluation / repair.Investigation summary: the org in question was returned and evaluated by nihon kohden repair center (nk rc).The issue of intermittent signal loss was not duplicated after 24 hours of extended testing.The issue is unlikely to be the result of a device malfunction.Signal loss indicates that the org is unable to communicate with the nk cnss and rnss.Possible root causes include ethernet cable failure due to physical damage or issues with the customer's network.Ticket 92328 was opened to report subsequent events of communication loss and nk rc could not duplicate the issue.The software of the org was upgraded, and the unit was returned to the customer.It is likely that the new software update was able to address and issue with version 04-31, which may have been contributing to the signal loss.As the returned device was found to be in good working condition by nk repair center, it is likely that version 04-31 was the sole cause but issues with the customer's network environment could also have been a contributing factor.As the device was found to be in good working condition in two product evaluations, a capa is not warranted.
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Event Description
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The biomedical engineer reported that there was intermittent signal loss displayed at the central nurse's station (cns).It would drop into a small bout of "signal loss" roughly every 10 minutes, or it would go into a longer period of signal loss for up to 3 minutes.The bed tile would show "cannot analyze" on the cns screen, then the data would disappear in full disclosure, and the event list showed "signal loss" for that period of missing data.The cns displayed a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.
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Search Alerts/Recalls
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