Model Number CNS-6801A |
Device Problems
Communication or Transmission Problem (2896); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2023 |
Event Type
malfunction
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Event Description
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The customer reported that the patient disappeared after wlan transport.There was no patient injury reported.
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Manufacturer Narrative
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The customer reported that the patient disappeared after wlan transport.According to the customer, when the bedside monitor (bsm) has its 1700 undocked, the 1700 can be seen at the central nurse's station (cns); however, when the 1700 is redocked the bsm will exit wlan fine, but at the cns, the admit button will display as if the patient was discharged.When the same bsms are being monitored by another cns, the issue does not occur.The customer changed out the cns with a spare.The customer will provide the logs to be reviewed.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.B6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: ni serial #: (b)(6).Device manufacturer date: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: no additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: rns: model #: ni serial #: (b)(6).Device manufacturer date: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.
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Manufacturer Narrative
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Details of complaint: the customer reported that the patient disappeared after wlan transport.According to the customer, when the bedside monitor (bsm) has its 1700 undocked, the 1700 can be seen at the central nurse's station (cns); however, when the 1700 is redocked the bsm will exit wlan fine, but at the cns, the admit button will display as if the patient was discharged.When the same bsms are being monitored by another cns, the issue does not occur.The customer changed out the cns with a spare.The customer will provide the logs to be reviewed.There was no patient injury reported.Investigation summary: the customer provided the cns logs.A definitive root cause could not be determined from the available information.We requested the bsm logs from this event as they reported that it displayed a "data send error" message; however, the customer was not able to provide such logs.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.B6 attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Attempt # 1: 04/02/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide the requested information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: no additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: rns: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: no 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) follow up 001.
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Event Description
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The customer reported that the patient disappeared after wlan transport.There was no patient injury reported.
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Search Alerts/Recalls
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