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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; CENTRAL MONITOR STATION
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NIHON KOHDEN CORPORATION; CENTRAL MONITOR STATION Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.The following is not regarding the the device information for the mdr itself, but to explain why this report was not late as the initial mdr was submitted on 03/26//21 at 08:04:05 pm pst pm per webtrader sent box.We also had written to the help desk about this at emdr@fda.Hhs.Gov.The mdr was filed on the due date of 03/26/21, but the acknowledgements did not arrive till 03/27/2021.Below are the acknowledgements from the initial submission with the time stamps that illustrate that the mdr was filed on time and not late.Messageid: (b)(4).Coreid: (b)(4).Datetime receipt generated: 03-26-2021, 23:05:20."cdrh has received your submission" ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.(b)(4), 20210326200303 sat mar 27 10:57:36 edt 2021, 0 1 form 3500a - icsr r2 passed.Submission summary environment: ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.Submission type: form 3500a - icsr r2.Core id: (b)(4).Batch id: 20210326200303.Date entered: sat mar 27 10:57:36 edt 2021.Summary: passed: 1, failed: 0.Report list: report number: 2080783-2021-00171, passed.
 
Event Description
The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.
 
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Brand Name
NI
Type of Device
CENTRAL MONITOR STATION
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key11579920
MDR Text Key280471935
Report Number2080783-2021-00171
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 04/05/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2021
Distributor Facility Aware Date03/26/2021
Event Location Hospital
Date Report to Manufacturer04/05/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/27/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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