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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 Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.They later stated that this was not a one time incident and that they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to that cns.No patient harm reported.
 
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.They later stated that this was not a one time incident and that they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to that cns.No patient harm reported.
 
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Brand Name
CNS-6201A
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 Key11708220
MDR Text Key280542490
Report Number2080783-2021-00232
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921114131
UDI-Public04931921114131
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 04/22/2021
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-6201A
Device Catalogue NumberPU-621RA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2021
Distributor Facility Aware Date03/23/2021
Device Age97 MO
Event Location Hospital
Date Report to Manufacturer04/22/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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