Model Number CNS-6201A |
Device Problems
Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme) reported that the central nurse's station (cns) and remote nurse's station (rns) were in communication loss.They switched the cns out with another, and communication loss occurred again.After extensive troubleshooting, nk ts found that the issue was caused by a failed switch.The part number of the replacement switch was provided the customer to resolve the issue.No patient harm was 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 products: the following device was being used in conjunction with the cns: rns: model #: a/rns-9703.S/n #: (b)(4).
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Event Description
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The biomedical engineer (bme) reported that the central nurse's station (cns) and remote nurse's station (rns) were in comm loss.
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Event Description
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The biomedical engineer (bme) reported that the central nurse's station (cns) and remote nurse's station (rns) were in comm loss.
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Manufacturer Narrative
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Details of the complaint: on (b)(6) 2020, the biomedical engineer (bme) at (b)(6) reported that the central nurse's station (cns) (pu-621ra sn: (b)(6) ) was intermittently experiencing communication loss.Service requested/ performed: nka support worked with the customer to troubleshoot the issue.The communication loss was found to be caused by duplicate ip address.Once the ip's were fixed, the communication loss went away.A makeshift switch was also found to cause communication loss.The switch was bypassed, and all cabling was connected to different switches, restoring communication.Information was provided for the customer to purchase a replacement switch.Investigation summary: the unit was not returned and no nka evaluation was performed.The customer complaint was resolved with nka assistance in correcting duplicate ip's and removal of a failed switch.No cns repair or exchange was performed in the ticket.The root cause of the communication loss is determined to be network issues caused by a failed switch and duplicate ip address.The reported issue is not suspected to involve a malfunction of the cns.The residual risk after actions taken in design and labeling was determined to be acceptable.The overall risk is determined to be low.Manufacturer's hazard analysis determined the residual risk of pu-621ra communication loss is acceptable.The reported issue does not require further investigation through the capa process.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the cns: rns: model #: a/rns-9703 serial #: (b)(6).
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Search Alerts/Recalls
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