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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

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NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM Back to Search Results
Model Number CNS-6801A
Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported that they were having site-wide communication loss.Nk is continuing to work with 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: brand name.Model number.Catalog number.Serial number.Udi number.Approximate age of device.No serial number was provided, so the age of the device is unknown.Pma/510(k) number.Device manufacturer date.Concomitant medical device: the following devices were being used in conjunction with the cns: bsms: no model or serial numbers were provided.
 
Event Description
The customer reported that they were having site-wide communication loss.No patient harm was reported.
 
Event Description
The customer reported that they were having site-wide communication loss.No patient harm was reported.
 
Manufacturer Narrative
Details of complaint: the customer reported they were having site-wide comm loss with all the monitored bedside monitors (bsms).No patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps with the customer and discovered the network was operating on one switch.Nk ts requested assistance from clinical information technology support (cits) to further troubleshoot the issue.Cits verified ip and host table addresses but found the only working bed to have the same ip as the server.Two of the beds had the same address.And the bsm's were all changed to auto ip with different settings.Cits discovered the disconnect was the firewall between the hospital network and the enterprise gateway.The wlan bridge needed the ip and mac addresses of the bsm's.Cits advised the facility to troubleshoot the issue on their end as we do not have access to the facility's network.The root cause is determined to be environment (facility network).Permissions for ip and mac address are being prevented due to the network settings.Additional information: b4 date of this report d8 was this device serviced by a third party? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.
 
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Brand Name
CNS-6801A
Type of Device
CENTRAL MONITOR SYSTEM
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
tomioka city, gunma 370-2 314
JA   370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key10371007
MDR Text Key204203092
Report Number8030229-2020-00428
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921131640
UDI-Public04931921131640
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/05/2020,01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCNS-6801A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/05/2020
Distributor Facility Aware Date07/07/2020
Event Location Hospital
Date Report to Manufacturer08/05/2020
Initial Date Manufacturer Received 07/07/2020
Initial Date FDA Received08/05/2020
Supplement Dates Manufacturer Received01/20/2023
Supplement Dates FDA Received01/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
BSMS; BSMS
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