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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 or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the power went out in some parts of the hospital and the power was down long enough to drain the uninterrupted power supply (ups) back up battery power causing the central nurse's station (cns) to be stuck in the splash screen.The bme stated that the nurses are still able to pull the patient information off of the bedside monitors (bsm) in this department, so no missed events or patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue, but the customer declined and stated they would be sending the device into nihon kohden for service.
 
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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 Key13237996
MDR Text Key286775390
Report Number2080783-2022-02309
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 01/12/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2022
Distributor Facility Aware Date12/15/2021
Device Age74 MO
Event Location Hospital
Date Report to Manufacturer01/12/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/12/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BEDSIDE MONITORS (BSM); UNINTERRUPTED POWER SUPPLY (UPS)
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