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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 Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
The nurse reported that the central nurse's station (cns) display was giving off a yellow hue, and the lines and wording on the application appeared blurry and was very hard to read.Nihon kohden technical support (tech support) instructed the nurse to contact the biomed as it could be an issue with a dvi cable.The biomed responded that the rbg setting on the kvm receiver used with the cns was adjusted to resolve the issue.No patient harm was reported.
 
Event Description
The nurse reported that the central nurse's station (cns) display was giving off a yellow hue, and the lines and wording on the application appeared blurry and was very hard to read.Nihon kohden technical support (tech support) instructed the nurse to contact the biomed as it could be an issue with a dvi cable.The biomed responded that the rbg setting on the kvm receiver used with the cns was adjusted to resolve the issue.No patient harm was reported.
 
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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
MDR Report Key12242813
MDR Text Key281994422
Report Number2080783-2021-01430
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921131640
UDI-Public04931921131640
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 07/28/2021
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
Device Catalogue NumberPU-681RA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2021
Distributor Facility Aware Date06/28/2021
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer07/28/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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