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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 Electrical Power Problem (2925); Unintended Application Program Shut Down (4032)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices and would not boot back up into windows.No patient harm was reported.The transmitter devices are currently being monitored by an rns in the department.The cns has been returned to nihon kohden and is awaiting evaluation.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.Additional device information: the following devices were being used in conjunction with the cns: transmitters: no model numbers and serial numbers were provided, ups (3rd party device): no model and serial number was provided, rns: no model and serial number was provided.
 
Event Description
It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices.No patient harm was reported.
 
Event Description
It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices.No patient harm was reported.
 
Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported the cns-6201a (pu-621ra sn: (b)(6) ) would not boot into windows.The device had been stalled at the operation system set up screen since the night of 11/15/19.The facility had a failed generator test on 11/15/19 and the entire hospital lost power, including back up power.Service requested/performed: the unit was returned to nka for repair; the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: there was no physical damage in initial evaluation.Verify the complaint: cns did not boot up into windows.Problem reported was duplicated.Nihon kohden replaced all the part(s) below and issue is resolved.9000006111a hard drive, 500gb, cns-6201 2 ea.All the malfunctioning part(s) were replaced.The unit was tested per the operator's/service manual.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation conclusion: the root cause is determined to be total loss of power at the facility, leading to improper shutdown of the cns and corruption of the hard drives.The issue was resolved upon replacing the hard drives and the unit was tested to operate within specifications.From the information available, the cns was operating within specifications, however became damaged as the specified operational power requirements were not met.Based on the information provided in the hazard analysis, operator's manual, and hha, the overall risk is low.Additional device information: d11 & c2: the following devices were being used in conjunction with the cns: transmitters: no model numbers and serial numbers were provided.Ups (3rd party device): no model and serial number was provided.Rns: no model and serial number was provided.
 
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Brand Name
CNS-6201A
Type of Device
CENTRAL MONITOR SYSTEM
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
MDR Report Key9441072
MDR Text Key200812027
Report Number8030229-2019-00709
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921114131
UDI-Public04931921114131
Combination Product (y/n)N
PMA/PMN Number
K102376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/19/2020
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 Manufacturer12/04/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2020
Distributor Facility Aware Date02/18/2020
Device Age98 MO
Event Location Hospital
Date Report to Manufacturer02/19/2020
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received02/18/2020
Supplement Dates FDA Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TRANSMITTERSUPSRNS; TRANSMITTERSUPSRNS
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