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 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that this facility is having tele communication dropping out for 30 seconds.The teles go into communication loss (comm loss) for all the beds then they go into bed not found and then come out of comm loss.Technical support (ts) asked the customer to check the org closet to see if the org's can be rebooted and check for error lights or any error lights on the switches.The customer stated he didn't see any error lights, but turned off the orgs for 30 seconds and rebooted the central nurse's station (cns); however, this did not resolve the issue.The customer will send in the unit to be repaired.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.D10 concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni.Serial #: ni.Device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: ni.D10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: ni.
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Event Description
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The customer reported that this facility is having tele communication dropping out for 30 seconds.There was no patient injuryreported.
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Manufacturer Narrative
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Details of complaint: the customer reported that this facility is having tele communication dropping out for 30 seconds.The teles go into communication loss (comm loss) for all the beds then they go into bed not found and then come out of comm loss.Technical support (ts) asked the customer to check the org closet to see if the org's can be rebooted and check for error lights or any error lights on the switches.The customer stated he didn't see any error lights, but turned off the orgs for 30 seconds and rebooted the central nurse's station (cns); however, this did not resolve the issue.The customer will send in the unit to be repaired.Investigation summary: the reported issue was duplicated on the returned device.An ip address mismatch was found on the device.The ip address was corrected to resolve the issue.The software was also upgraded on the device.As the issue was found to be related to ip address, it is unlikely that the cause is related to a malfunction.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.Manufacturer references # (b)(4).
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Event Description
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The customer reported that this facility is having tele communication dropping out for 30 seconds.There was no patient injury reported.
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Search Alerts/Recalls
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