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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

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NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM Back to Search Results
Model Number CNS-6201A
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 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
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).
 
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) and remote nurse's station (rns) were in comm loss.
 
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) and remote nurse's station (rns) were in comm loss.
 
Manufacturer Narrative
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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Brand Name
CNS-6201A
Type of Device
CENTRAL MONITOR SYSTEM
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
MDR Report Key10299573
MDR Text Key200636478
Report Number8030229-2020-00396
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921114131
UDI-Public04931921114131
Combination Product (y/n)N
PMA/PMN Number
K102376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/20/2020,10/28/2020
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-6201A
Device Catalogue NumberPU-621RA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/20/2020
Distributor Facility Aware Date06/21/2020
Device Age77 MO
Event Location Hospital
Date Report to Manufacturer07/20/2020
Initial Date Manufacturer Received 06/21/2020
Initial Date FDA Received07/20/2020
Supplement Dates Manufacturer Received08/11/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RNS; RNS
Patient Outcome(s) Required Intervention;
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