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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 No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the video splitter video out has stopped being displayed on the remote displays of the central nurse's station (cns).They stated that they have narrowed the issue to the power supply by swapping in a working power supply and the video started working again.Qa contacted the customer to confirm if this this remote display was mirroring the main screen to see if all patients were being monitored on the main screen, or if it was monitoring different patients than what was being monitored on the main cns screen.The customer has been unresponsive.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 Key13115813
MDR Text Key285751232
Report Number2080783-2021-02320
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 Biomedical Engineer
Type of Report Initial
Report Date 12/29/2021
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 FDA12/29/2021
Distributor Facility Aware Date11/30/2021
Device Age35 MO
Event Location Hospital
Date Report to Manufacturer12/29/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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