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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 Problem Electrical Power Problem (2925)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.The cns is currently plugged into an outlet.The customer is requesting the ups part number and it was provided.The customer was then transferred to customer service for pricing on the part.There was no patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
 
Event Description
The customer reported that the uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.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 Key12132587
MDR Text Key281431216
Report Number2080783-2021-00395
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 07/07/2021
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 FDA07/07/2021
Distributor Facility Aware Date06/08/2021
Device Age74 MO
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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