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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); Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse station (cns) screen seemed to be frozen and was not reacting to the touch or movement of the mouse even though they were able to see patients on the screen.No patient harm was reported.Attempt #1: on 08/23/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: on 08/24/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
 
Event Description
The biomedical engineer (bme) reported that the central nurse station (cns) screen seemed to be frozen and was not reacting to the touch or movement of the mouse even though they were able to see patients on the screen.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 Key12363532
MDR Text Key268282203
Report Number2080783-2021-01550
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921131640
UDI-Public04931921131640
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/24/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2021
Distributor Facility Aware Date08/01/2021
Device Age10 MO
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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