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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 Communication or Transmission Problem (2896)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2019
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) was in communication loss on all telemetry transmitters that are being monitored.Then later told that the comm loss is happening sporadically on all the telemetry transmitters.The cns reported windows error: "cns6201.Exe - corrupt file.The file or directory c:\programs files\nihon kohden\cns-6200\storage\bed015 is corrupt and unreadable.Please run the chkdsk utility." nihon kohden technical support told the customer to gather logs and run a check disk, and requested they let us know the results when they have it.No response from them yet.No patient harm 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.Additional device information: concomitant medical device: the following devices were used in conjunction with the cns.Multiple patient receivers model: org-9110a sn: 00186.Model: org-9110a sn: 00187.Telemetry transmitters model: zm-541pa sn: 00450.Model: zm-541pa sn: 00650.Model: zm-541pa sn: 00786.Model: zm-541pa sn: 02061.Model: zm-541pa sn: 02238.Model: zm-541pa sn: 02345.Model: zm-541pa sn: 02369.Model: zm-541pa sn: 02378.Model: zm-541pa sn: 02484.Model: zm-541pa sn: 02551.Model: zm-541pa sn: 02626.Model: zm-541pa sn: 02677.Model: zm-541pa sn: 02748.Model: zm-541pa sn: 02895.Model: zm-541pa sn: 02899.
 
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was in communication loss on all telemetry transmitters that are being monitored.Then later told that the comm loss is happening sporadically on all the telemetry transmitters.The cns reported windows error: "cns6201.Exe - corrupt file.The file or directory c:\programs files\nihon kohden\cns-6200\storage\bed015 is corrupt and unreadable.Please run the chkdsk utility." nihon kohden technical support told the customer to gather logs and run a check disk, and requested they let us know the results when they have it.No response from them yet.No patient harm reported.
 
Event Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was in communication loss on all telemetry transmitters that are being monitored.Then later told that the comm loss is happening sporadically on all the telemetry transmitters.The cns reported windows error: "cns6201.Exe - corrupt file.The file or directory c:\programs files\nihon kohden\cns-6200\storage\bed015 is corrupt and unreadable.Please run the chkdsk utility." nihon kohden technical support told the customer to gather logs and run a check disk, and requested they let us know the results when they have it.No response from them yet.No patient harm reported.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was in communication loss on all telemetry transmitters that were being monitored.The cns reported a windows error: "cns6201.Exe - corrupt file.The file or directory c:\programs files\nihon kohden\cns-6200\storage\bed015 is corrupt and unreadable.Please run the chkdsk utility." nihon kohden technical support advised the customer to gather the logs, run a check disk, and then requested they let us know the results when they have it.No response from them yet.No patient harm was reported.Service requested / performed: troubleshooting.Nihon kohden technical support advised the customer to gather the log files, run a check disk, and then requested they let nk know the results when they have them.No response has yet been received from them.Investigation summary: an irc was generated, (irc-nka300190460) to assist in the investigation of the issue by nkc engineers.Per the irc investigation result, the customer was advised to verify if the hdd was corrupted physically and reinstall from the os.The root cause of the issue was determined to be hard drive corruption.The overall risk of this event is high.The reported issue does not require further investigation through capa process.Hha has been completed for the cns-6201a hard drives failure.Capa 19-022 was initiated and rejected based on rationale provided in hha 20-001.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: multiple patient receivers: model #: org-9110a; (b)(6).Model #: org-9110a; (b)(6).Telemetry transmitters: model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).Model #: zm-541pa; (b)(6).
 
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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 Key9533655
MDR Text Key200825045
Report Number8030229-2019-00751
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 user facility
Type of Report Initial,Followup
Report Date 12/30/2019,08/10/2021
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 FDA12/30/2019
Distributor Facility Aware Date12/05/2019
Device Age106 MO
Event Location Hospital
Date Report to Manufacturer12/30/2019
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received07/13/2021
Supplement Dates FDA Received08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORG-9110A SN 00186; ORG-9110A SN 00186; ORG-9110A SN 00187; ORG-9110A SN 00187; ZM-541PA SN 00450; ZM-541PA SN 00450; ZM-541PA SN 00650; ZM-541PA SN 00650; ZM-541PA SN 00786; ZM-541PA SN 00786; ZM-541PA SN 02061; ZM-541PA SN 02061; ZM-541PA SN 02238; ZM-541PA SN 02238; ZM-541PA SN 02345; ZM-541PA SN 02345; ZM-541PA SN 02369; ZM-541PA SN 02369; ZM-541PA SN 02378; ZM-541PA SN 02378; ZM-541PA SN 02484; ZM-541PA SN 02484; ZM-541PA SN 02551; ZM-541PA SN 02551; ZM-541PA SN 02626; ZM-541PA SN 02626; ZM-541PA SN 02677; ZM-541PA SN 02677; ZM-541PA SN 02748; ZM-541PA SN 02748; ZM-541PA SN 02895; ZM-541PA SN 02895; ZM-541PA SN 02899; ZM-541PA SN 02899
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