Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM Back to Search Results
Model Number CNS-6201A
Device Problems Image Display Error/Artifact (1304); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) had frozen and the bme attempted to reboot the station by pressing the power button to shut it off.When the station was rebooted, the application is now stuck in the cns splash screen.No patient harm was reported.Nihon kohden technician advised the bme that it is likely one of the hdd drives that is corrupt in the cns.The bme had a spare hdd drive and was able to rebuild it and install it in the cns which resolved the reported issue.There were no further issues with the cns.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) had frozen and the bme attempted to reboot the station by pressing the power button to shut it off.When the station was rebooted, the application is now stuck in the cns splash screen.No patient harm was reported.Nihon kohden technician advised the bme that it is likely one of the hdd drives that is corrupt in the cns.The bme had a spare hdd drive and was able to rebuild it and install it in the cns which resolved the reported issue.There were no further issues with the cns.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12780749
MDR Text Key284986749
Report Number2080783-2021-01912
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921114131
UDI-Public04931921114131
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/09/2021
Distributor Facility Aware Date10/11/2021
Device Age83 MO
Event Location Hospital
Date Report to Manufacturer11/09/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-